THESIS – SYNOPSIS



DISSERTATION – SYNOPSIS

DR. HEENA NAZ KAOUSER

POST GRADUATE STUDENT

DEPARTMENT OF PERIODONTICS

BATCH 2013-2016

FAROOQIA DENTAL COLLEGE AND HOSPITAL

MYSORE

Rajiv Gandhi University of Health Sciences, Bangalore,

Karnataka

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE

KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

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|1. |NAME OF THE CANDIDATE AND |DR. HEENA NAZ KAOUSER |

| |ADDRESS |POST GRADUATE STUDENT, |

| |(IN BLOCK LETTERS) |DEPARTMENT OF PERIODONTICS, |

| | |FAROOQIA DENTAL COLLEGE AND HOSPITAL, |

| | |UMAR KHAYAM ROAD, EIDGAH, |

| | |MYSORE – 570021. |

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|2. |NAME OF THE INSTITUTION |FAROOQIA DENTAL COLLEGE AND HOSPITAL, |

| | |UMAR KHAYAM ROAD, EIDGAH, |

| | |MYSORE – 570021 |

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|3. |COURSE OF STUDY AND SUBJECT |MASTER OF DENTAL SURGERY. |

| | |PERIODONTICS |

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|4. |DATE OF ADMISSION OF COURSE |26TH JULY 2013 |

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|5. |TITLE OF THE TOPIC |

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| |COMPARATIVE EVALUATION OF OZONATED OIL AND CHLORINE DI OXIDE (Freshclor®) AS LOCAL IRRIGATION IN THE MANAGEMENT OF CHRONIC PERIODONTITIS. |

| |[A CLINICAL, MICROBIOLOGIC AND RADIOGRAPHIC STUDY]. |

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| |BRIEF RESUME OF THE INTENDED WORK: |

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| |NEED FOR THE STUDY: |

| |Periodontal disease is a multifactorial inflammatory disease. The development of periodontal disease has been thought to be associated with|

| |oral anaerobic species such as black pigmented Porphyromonas gingivalis and Actinobacillus actinomycetemcomitans (Aa) in subgingival |

| |environment. It is generally accepted that tissue destruction seen in periodontal disease results from the harmful effects of host immune |

| |response to the action of pathogenic bacteria. Elimination of periopathogens containing biofilms remains the primary goal of periodontal |

| |treatment. Apart from bacteria certain viruses and fungi are also present in sub gingival plaque that have been associated with periodontal|

| |disease. Candida albicans has been recovered from periodontal pockets in a large number of patients with chronic periodontitis1. |

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| |Removal of dental plaque thus forms an important part of controlling and treating periodontal disease which brings about both qualitative |

| |as well as quantitative changes in subgingival microflora. A number of chemical adjuncts have been used to improve the outcome of |

| |mechanical oral hygiene procedures of which Ozonated oil and Chlorine di oxide have pronounced antimicrobial effects on gram positive and |

| |gram negative bacteria as well as viruses and fungi1. |

| | |

| |An alternative approach to conventional antimicrobial or antiseptic agents in the suppression of subgingival bacteria is to inhibit their |

| |growth by changing the subgingival environment, which has been shown to be highly anaerobic with a prevailing low oxygen tension.Various |

| |agents such as molecular oxygen, hyperbaric oxygenation and hydrogen peroxide have been applied. It has been showed that repeated |

| |subgingival oxygen irrigation in previously untreated deep periodontal pockets resulted in a significant clinical improvement of the |

| |periodontal baseline conditions. Recently, ozone therapy is gaining popularity in various treatment modalities in the field of medicine, |

| |dentistry, veterinary, food industry, water treatment, etc. In dentistry, ozone is being successfully utilized for the treatment of dental |

| |caries1. |

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| |Ozone is an unstable gas and it quickly gives up nascent oxygen molecules to form oxygen gas. It is widely being used as gaseous, aqueous |

| |and oil form in medical field and dental field2. |

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| |Ozonated oils are useful in treating gingivitis, periodontitis, periimplantitis, surgical cuts, prophylaxis, implantation, extraction, |

| |wound healing, mouth and tongue ulceration, superficial burns, abscess, herpes infections and candidiasis. It is widely being used in |

| |restorative dentistry and endodontics3. |

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| |Ozonated oil has a valuable antimicrobial activity against bacteria, fungi, viruses4. |

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| |Chlorine di oxide (Freshclor®) mouthwash which has been recently introduced is very effective at reducing malodour and halitosis. It is |

| |used as topical antiseptic for oral cavity and for dentures5. |

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| |Chlorine di oxide penetrates the bacterial cells and reacts with vital amino acids in the cytoplasm to kill the organisms. It is |

| |bactericidal and is harmless for human cells6. |

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| |It is used to reduce or prevent plaque formation and also treating oral diseases, gingivitis and periodontitis. Preferred concentrations |

| |are 0.005% to 0. 5%7. |

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| |Chlorine di oxide is odorless and tasteless and it does not cause burning, drying or staining with continued use as compared to traditional|

| |alcohol and chlorhexidine based mouth rinse. It is widely and safely used as high antibacterial mouthwash8. |

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| |Although few studies are available on Ozonated oil and Chlorine di oxide mouth wash, till date there has been no study comparing Ozonated |

| |oil with Chlorine di oxide mouth wash. Thus the aim of the study is to evaluate the effect of oral irrigation with Ozonated oil and |

| |Chlorine di oxide (Freshclor®) mouth wash in moderately deep periodontal pockets on clinical parameters, microbial profile and radiographic|

| |parameters of chronic and aggressive periodontitis. |

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| |REVIEW OF LITERATURE: |

| |Kshitish and Laxman conducted a study using ozonated water and chlorhexidine mouthrinse in patients suffering from chronic generalised |

| |periodontitis patients and observed higher percentage reduction in plaque index, gingival index and bleeding index using ozonated water |

| |alone. There was no antibacterial effect on Pg and Tf by using ozone and chlorhexidine and the reduction of Aa using ozone was appreciable |

| |as compared to chlorhexidine. Antifungal effect of ozone from baseline (37%) to 7th day (12.5%) was significant unlike chlorhexidine which |

| |did not demonstrate any antifungal effect1. |

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| |Ramzy et-al treated the periodontal pockets by ozonated water in 22 patients suffering from aggressive periodontitis pockets once weekly, |

| |for 4 weeks using blunt tipped sterile plastic syringe and noticed high improvement regarding pocket depth, plaque index, gingival index. |

| |Bacterial count was recorded related to quadrants treated by scaling and root planing together with ozone application and reported reduced |

| |bacterial count in sites treated with ozonised water4. |

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| |David D, Alissa L.Villhaver B.S. conducted a study to determine the bactericidal activity of a stabilised chlorine di oxide oral rinses |

| |compared to products currently available in market and results demonstrated that chlorine di oxide oral rinse has potential for providing |

| |therapeutic benefit. It proved bactericidal against the periodontal pathogens at 5 mins over chlorhexidine rinse5. |

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| |L.A.Sechi, I Lezcano, N.Nunez, conducted a study to evaluate the antimicrobial effect of ozonized sunflower oil (Oleozon) on different |

| |bacterial species isolated from different sites which proved a valuable antimicrobial activity against Staphylococci, Streptococci, |

| |Enterococci, Pseudomonas and Escherichia coli but mycobacteria were more susceptible to Oleozon than other bacteria9. |

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| |Amr.A.M. E.L.Karargy conducted a study on patients with generalized moderate periodontitis and showed that use of Oleozon gel led to |

| |significant increase in bone density, bone height and clinical attachment level10. |

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| |Alaa.I, Abdel Hamid conducted an experimental study to investigate the resulting histologic regeneration after the use of Oleozon gel in |

| |the treatment of induced periodontal defects in dogs and concluded that Oleozon gel demonstrated higher bone formation, greater gain of |

| |clinical attachment and regeneration of attachment apparatus11. |

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| |OBJECTIVES OF THE STUDY- |

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| |Evaluation and comparison of the effects of oral irrigation with Ozonated oil and Chlorine di oxide on clinical parameters such as |

| |Plaque index by Silness and Loe (1964) |

| |Gingival index by Loe and Silness (1963) |

| |Modified sulcus bleeding index by Mombelli, M.A.Van Oosten, E.Schurch.Jr & N.P.Land (1987) |

| |Pocket depth |

| |Clinical attachment level |

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| |2. To assess and compare the effects of Ozonated oil and Chlorine di oxide mouth wash on following micro organisms |

| |Bacterias - Actinobacillus actinomycetemcomitans (Aa) |

| |- Porphyromonas gingivalis(Pg) |

| |Fungus- Candida albicans(Ca) |

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| |3. Radiographic investigations- To assess the bone fill in the infrabony defects using intra oral peri apical radiographs with |

| |millimeter grid scale. |

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| |7. MATERIALS AND METHODS |

| |7.1 SOURCE OF DATA |

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| |15 patients of either gender in the age group of 20 – 60, suffering from chronic and aggressive periodontitis who will report to the |

| |Department of Periodontics, Farooqia Dental College and Hospital, Mysore. |

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| |7.2 METHOD OF COLLECTION OF DATA – |

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| |A brief case history will be recorded from all 15 patients and an informed consent will be taken from all the patients. |

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| |INCLUSION AND EXCLUSION CRITERIA – |

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| |INCLUSION CRITERIA- |

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| |Minimum of 20 teeth to be present in every patient. |

| |Minimum of 4 sites with more than 5mm of pocket depth |

| |Minimum of 6 sites that bleed on probing. |

| |Patient in age group of 20-60 years suffering from generalised chronic and aggressive periodontitis |

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| |EXCLUSION CRITERIA- |

| |Patients suffering from known systemic diseases |

| |Patients who are pregnant and lactating |

| |Patients who are smokers and alcoholics |

| |Patients who had received any chemotherapeutic mouth rinse or oral irrigation during past 6 months. |

| |Patients who received surgical or non surgical therapy in last 6 months. |

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| |METHODOLOGY- |

| |STUDY DESIGN: |

| |A randomized split mouth design will be performed on 15 patients. |

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| |METHOD: |

| |The procedure will be explained before the start of the study. |

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| |The study period is divided into 4 intervals of 7 days, with a wash out period of 4 days between each interval. |

| |1st Interval : baseline (0 day) to day 7 |

| |2nd Interval : day 11 to day18 |

| |3rd Interval : day 22 to day 29 |

| |4th Interval : day 33 to day 40 |

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| |On the 1st and 3rd interval, (day 0, day 7, day 22, day 29), one side of the mouth will be irrigated with Ozonated oil via blunt 25 G |

| |needle which will be inserted 3mm subgingivally. And on the 2nd and 3rd interval (day 11, day 18, day 33, day 40), the contralateral side |

| |of the mouth will be irrigated with Chlorine di oxide mouth wash via magnetostrictive ultrasonic insert, with a medium power setting. |

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| |The subgingival pooled plaque samples will be collected on baseline (0day) and on all the intervals from both the sides. |

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| |Sample collection: Subgingival plaque will be collected using sterilized Gracey curette by inserting it subgingivally into the deeepest |

| |portion of the periodontal pocket, transported using Sodium Thioglycolate medium and microbiological analysis will be done for Aa, Pg and |

| |Candida albicans by Polymerase Chain Reaction (PCR). |

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| |The procedure of radiographic investigations will be done on baseline, 6th month and 9th month. |

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| |CLINICAL PARAMETERS: |

| |Brief case history will be recorded and intra oral examination will be done at each interval. Periodontal health status will be assessed |

| |using - |

| |Plaque Index - Silness and Loe (1964) |

| |Gingival Index - Loe and Silness (1963) |

| |Gingival Bleeding Index - Mombelli, M.A.Van Oosten, E.Schurch.Jr & N.P.Land (1987) |

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| |After one month from baseline the following parameters will be recorded and repeated at 6th month and 9th month. |

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| |Probing Pocket Depth |

| |Clinical Attachment level |

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| |Probing pocket depth will be assessed with the help of a standard UNC 15 graduated periodontal probe. Acrylic Stents will be fabricated to |

| |standardize the entry of probe into the periodontal pockets during recall visits. |

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| |Probing Depth will be recorded as the distance between the free gingival margin and the base of the sulcus. |

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| |Clinical Attachment Loss will be measured as the distance between the CEJ and the base of the pocket. |

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| |OCCLUSAL STENT FABRICATION: |

| |Occlusal stents will be fabricated using self cure acrylic on a study cast model obtained from an alginate impression. |

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| |The occlusal stent will be made to cover the occlusal surface of the tooth being treated and atleast one occlusal surface on either side of|

| |the adjacent teeth in the mesial and distal directions. It will be extended apically on the buccal and lingual surfaces to cover the |

| |coronal third of the tooth being involved. |

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| |Grooves would be placed using a low speed cylindrical bur, which would be marked with a pencil where the probe makes a contact with the |

| |stent, when inserted into the pocket in the patient’s mouth. |

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| |CLINICAL MEASUREMENTS USING OCCLUSAL STENTS: |

| |Using apical margin of the acrylic stent as a fixed reference point (RP), the following measurements will be recorded at the proximal line |

| |angle of the tooth with the associated bone defect – |

| |RP to gingival margin(GM) |

| |RP to CEJ |

| |RP to base of the pocket(BOP) |

| |Using this the clinical parameters will be recorded- |

| |POCKET PROBING DEPTH = {RP to BOP}- {RP to GM} |

| |CLINICAL ATTACHMENT LEVEL = {RP to BOP} – {RP to CEJ} |

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| |RADIOGRAPHIC ANALYSIS |

| |Bone fill will be calculated using IOPA radiographs with millimeter grid scale. To standardize, putty index will be made and the patient |

| |will be asked to bite on it along with that of the holder. The depth of the defect will be measured from the CEJ to the base of the defect.|

| |Panoramic radiographs will be taken at baseline, 6th month and 9th month. |

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| |STATISTICAL ANALYSIS |

| |Statistical analysis will be done. |

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| |7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? IF SO, PLEASE |

| |DESCRIBE BRIEFLY – |

| |YES. |

| |OPG and IOPAR. |

| |The participant of the study will be requested to fill a consent form. |

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| |7.4 HAS THE ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3? |

| |Yes, Ethical clearance letter is enclosed. |

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| |8. LIST OF REFERENCES: |

| | |

| |Durga Kshitish, Vandana K.Laxman. The use of Ozonated water and 0.2% Chlorhexidine in the treatment of periodontitis patients - A Clinical |

| |and Microbiologic study. Indian J.Dent Res.2010;21(3):341-348. |

| | |

| |Gupta G, Mansi B. Ozone Therapy in periodontics. Journal of Medicine and Life 2012;5(1):59-67. |

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| |Rania S.Mosallam, A.Nemat Ahmeed, EL.Hoshy and Shiro Suzuki. Effect of Oleozon on healing of exposed pulp tissue. Journal of American |

| |science.2011;7(5):38-44. |

| | |

| |Ramzy M.I, Gomaa.H.E, Mostafa M.I and Zaki B.M. Management of Aggressive Periodontitis using Ozonized water. Egypt.Med J.N.R.C |

| |2005;6(1):229-245. |

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| |David Drake, Alissa L, Vill Haver, B.S. An in vitro Comparative Study determining Bactericidal activity of stabilized Chlorine di oxide and|

| |other oral rinses. J.Clin.Dent 2011;22:1-5. |

| | |

| |Shinada K, Masayuki Ueno, et al. Effects of a Mouth Wash with Chlorine di oxide on oral malodour and salivary bacteria. A randomized |

| |placebo-controlled 7 day trials. Trials Journal 2010;11:14. |

| | |

| |Ratcliff. Methods for preventing periodontitis. United States Patent. Patent no: 4886, 657,Dec1,1989. |

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| |Shubangi Mani, Ameet Nani, Rajiv Saini. Chlorine di oxide: A potential mouth rinse for oral health. Int J Experiment Dent Sci |

| |2012;1(2):118. |

| | |

| |L.A.Sechi, I.Lezcano, N.Nunez, M Espim, I.Dupre A.Pinna. Antibacterial activity of Ozonized sunflower oil (Oleozon). Journal of applied |

| |Microbiology 2001;90:279-284. |

| | |

| |Amr.A.M. ELKargy and Alaa.I.Abdel Hamid. The use of Oleozon in treatment of Infrabony osseous defects. Egyptian Dental Journal. |

| |2009;55(1):1-12. |

| | |

| |Alaa I, Abdel Hamid. The use of Oleozon gel in the treatment of surgically induced two-wall Osseous defects in Mongrel Dogs (Histologic |

| |study). Journal of American Science;2012;8(9):1017-1023. |

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FAROOQIA DENTAL COLLEGE AND HOSPITAL, MYSORE.

Department of Periodontics

PATIENT CONSENT FORM

I ________________________ aged _________years, on my own volition hereby give consent to be a part of the clinical study conducted by HEENA NAZ KAOUSER, titled “COMPARATIVE EVALUATION OF OZONATED OIL AND CHLORINE DI OXIDE (Freshclor®) AS LOCAL IRRIGATION IN THE MANAGEMENT OF CHRONIC PERIODONTITIS. (A CLINICAL, MICROBIOLOGIC AND RADIOGRAPHIC STUDY)”.

I have been thoroughly briefed about the procedure including the complications, if any. I Volunteer to be a part of the study and present myself for reviews when required.

Patient’s signature :

Name :

Address :

Contact No :

Attending Doctor’s Signature:

Doctor’s Contact No:

Signature of witness: Date:

FAROOQIA DENTAL COLLEGE AND HOSPITAL, MYSORE.

Department of Periodontics

PATIENT INFORMATION SHEET

You are being requested to take part in a study titled “COMPARATIVE EVALUATION OF OZONATED OIL AND CHLORINE DI OXIDE (Freshclor®) AS LOCAL IRRIGATION IN THE MANAGEMENT OF CHRONIC PERIODONTITIS. (A CLINICAL, MICROBIOLOGIC AND RADIOGRAPHIC STUDY)”. The aim of the study is to evaluate the effect of oral irrigation with ozonated oil and chlorine di oxide (Freshclor®) mouth wash in moderately deep periodontal pockets on clinical parameters, microbial profile and radiographic parameters of chronic and aggressive periodontitis. This study will not alter your treatment plan. Such a procedure is done as a part of the treatment. This study shall only assess the outcome of your treatment procedure.

VOLUNTARY PARTICIPATION

Your participation in this project is voluntary. You can withdraw from it any time you wish. This will no way adversely affect the subsequent outcome of the treatment of your relationship with the operating doctor on inclusion to the project; you will be monitored regularly and you should present yourself for follow up as advised. Any additional expense for the project will be borne by the project fund and will not be charged to you.

RISK (IF ANY) TO THE PATIENT

There are no expected additional risks or side effects to the patient due to the project. Additional expenditure for the project will be borne by the project fund. Your attending doctor will answer any further queries. You are assured of total confidentiality of the data and your name will not be disclosed under any circumstance. In case of your withdrawal for any reason, the standard of your therapy will not change.

PROFORMA

TEST SITE 1/TEST SITE 2

Name: Age: Sex: M/F

OP No: Occupation:

Address and Phone No :

Initial preparation completed on :

Pocket selected for the study :

Preoperative radiographs of the area taken on:

Surgery done on :

|PERIODONTAL STATUS |

|Pathologic | | | |

|migration | | | |

| | | |3 |6 |9 |

|1 |Gingival Index (Loe and Silness) | | | | |

|2 |Plaque Index (Silness and Loe) | | | | |

|3 |Modified bleeding index (Mombelli, M.A.Van Oosten, | | | | |

| |E.Schurch Jr, N.P.Land) | | | | |

|Teeth selected for Site 1 | |

|Teeth selected for Site 2 | |

CLINICAL PARAMETERS RECORDING

|Sl. No |Measurement (in mm) |Baseline |Post – OP (in months) |

| | | |Three |Six |Nine |

|1 |Fixed reference point (FRP) to base of the pocket (BOP) | | | | |

|2 |Fixed reference point (FRP) to Cementoenamel junction | | | | |

| |(CEJ) | | | | |

|3 |Fixed reference point (FRP) to Gingival margin (GM) | | | | |

|Sl. No |Measurement (in mm) |Baseline |Post – OP (in months) |

| | | |Three |Six |Nine |

|1 |Pocket Depth | | | | |

| |FRP to BOP – FRP to GM | | | | |

|2 |Clinical attachment level | | | | |

| |FRP to BOP – FRP to CEJ | | | | |

|3 |Gingival margin position | | | | |

| |FRP to CEJ – FRP to GM | | | | |

RADIOGRAPHIC RECORDINGS (INTRAORAL PERIAPICAL RADIOGRAPH)

|Sl. No |Measurement (in mm) |Baseline |Post – OP (in months) |

| | | |Three |Six |Nine |

|1 |CEJ to the base of the defect | | | | |

|2 |CEJ to the alveolar crest of the defect | | | | |

|Sl. No |Patient Name |Register Number |Teeth treated with Site 1 |Teeth treated with Site 2 |

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