| CTRI Number |
CTRI/2016/10/007417 [Registered on: 27/10/2016] Trial Registered Retrospectively |
| Last Modified On: |
20/10/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two surgical procedures in chronic periodontitis patients. |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF TREATMENT OUTCOMES FOR CLASS II FURCATION DEFECTS BY OPEN FLAP DEBRIDEMENT (OFD) ALONE AND OPEN FLAP DEBRIDEMENT (OFD) WITH AUTOLOGOUS PLATELET RICH FIBRIN (PRF) MEMBRANE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshal Pradip Patil |
| Designation |
Post Graduate Student (Periodontology and Oral Implantology) |
| Affiliation |
S M B T Dental College, Sangamner |
| Address |
Department of Periodontology and Oral Implantology,
S M B T Dental College and Hospital,Ghulewadi,Amrutnagar,Sangamner,
Dist- Ahmednagar, Maharashtra, India 422 608
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9029762036 |
| Fax |
02425-222867 |
| Email |
drharshalppatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P S Rakhewar |
| Designation |
MDS, Professor ,Guide and HOD |
| Affiliation |
S M B T Dental College and Hospital, Sangamner |
| Address |
Department of Periodontology and Oral Implantology,
S M B T Dental College, Sangamner,
Dist- Ahmednagar, Maharashtra, India 422 608
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9370017313 |
| Fax |
02425-222867 |
| Email |
drpsrakhewar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshal Pradip Patil |
| Designation |
Post Graduate Student (Periodontology and Oral Implantology) |
| Affiliation |
S M B T Dental College, Sangamner |
| Address |
Department of Periodontology and Oral Implantology,
S M B T Dental College and Hospital,Ghulewadi,Amrutnagar,Sangamner,
Dist- Ahmednagar, Maharashtra, India 422 608
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9029762036 |
| Fax |
02425-222867 |
| Email |
drharshalppatil@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Harshal Pradip Patil |
| Address |
Department of Periodontology and Oral Implantology,
S M B T Dental College and Hospital, Ghulewadi,Amrutnagar,Sangamner,
Dist- Ahmednagar, Maharashtra, India 422 608
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harshal Pradip Patil |
SMBT Dental College, Sangamner |
Department of Periodontology and Oral Implantology,
S M B T Dental College and Hospital, Ghulewadi, Sangamner,
Dist- Ahmednagar, Maharashtra, India 422 608
Ahmadnagar
MAHARASHTRA |
9029762036
drharshalppatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MUHS Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patients in control group with Class II furcation defect |
Patients in control group with class II furcation defects will be treated with open flap debridement (OFD) alone |
| Intervention |
Patients in test group with class II furcation defect |
Patients in test group with class II furcation defects will be treated with open flap debridement(OFD) in combination with PRF |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with age group 25-55 years
2. Both males and females
3. The presence of buccal class II furcation defects in endodontically vital, asymptomatic teeth with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD)≥ 5 mm and horizontal PD ≥3 mm after phase I therapy (scaling and root planing).
4. Absence of any local anatomical limitations
5. Patient willing for surgery and ready to give written consent |
|
| ExclusionCriteria |
| Details |
1. Systemic illness known to affect the outcomes of periodontal therapy
2. Individuals allergic to medications
3. Pregnant or lactating women
4. Patients using tobacco in any form
5. Individuals with unacceptable oral hygiene (plaque index [PI] >1.5).
6. Teeth with interproximal intrabony defects, gingival recession, endodontic (pulpal) involvement, or mobility of tooth ≥Grade II will be excluded.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Probing depth, Clinical attachment level |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiographic evaluation |
6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/01/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The periodontal infection results from the subgingival colonization of periodontopathic bacteria. However, subgingival infection can cause anatomic changes in periodontal tissues ( i.e. Increased probing depth [PD], and furcation defects) that can produce local conditions that favor recurrence of disease. Periodontal treatment includes the surgical elimination of anatomic deformities by restoring lost supporting tissues. Periodontal regeneration refers to the reproduction or reconstitution of the lost or injured part. Guided tissue regeneration (GTR) is one technique with the most histologic documentation of periodontal regeneration in class II furcation defect. Various growth factors have been shown to accelerate the healing process. Platelet also releases growth factors which are natural biological mediators that regulate crucial cellular events involved in tissue repair. So platelet rich fibrin will provide growth factors and additionally the simplicity of procedure will help in treatment of class II furcation defect. The aim of this study is to evaluate the effectiveness of autologous platelet rich fibrin (PRF) membrane with open flap debridement (OFD) in the treatment of class II furcation defects compared to open flap debridement (OFD) alone |