CTRI Number |
CTRI/2019/05/019328 [Registered on: 24/05/2019] Trial Registered Prospectively |
Last Modified On: |
04/12/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Treatment of gum recession |
Scientific Title of Study
|
Evaluation of Patient Centered outcome with Platelet Rich Fibrin Membrane and Sub-Epithelial Connective Tissue Graft for the Treatment of Gingival Recession |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Ruchika Lulla |
Designation |
PG student |
Affiliation |
Sharad Pawar Dental College |
Address |
Nanak Nagar Near Nankani Mangal Karyalaya, Rampuri Camp
Amravati Datta Meghe Institute of Medical Sciences
Sharad Pawar Dental College, Sawangi (M), Wardha Wardha MAHARASHTRA 444603 India |
Phone |
7588752199 |
Fax |
|
Email |
ruchika.lulla@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Priyanka Jaiswal |
Designation |
Associate Professor |
Affiliation |
Sharad Pawar Dental College |
Address |
Sharad Pawar Dental College,
Sawangi (M)
Wardha Datta Meghe Institute of Medical Sciences
Sharad Pawar Dental College
Sawangi (M) Wardha MAHARASHTRA 442004 India |
Phone |
9960713010 |
Fax |
|
Email |
priyanka.banode@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Priyanka Jaiswal |
Designation |
Associate Professor |
Affiliation |
Sharad Pawar Dental College |
Address |
Sharad Pawar Dental College,
Sawangi (M)
Wardha Datta Meghe Institute of Medical Sciences
Sharad Pawar Dental College
Sawangi (M) Wardha MAHARASHTRA 442004 India |
Phone |
9960713010 |
Fax |
|
Email |
priyanka.banode@gmail.com |
|
Source of Monetary or Material Support
|
Datta Meghe Institute of Medical Sciences
Sharad Pawar Dental College
Sawangi (M)
|
|
Primary Sponsor
|
Name |
not applicable |
Address |
not applicable |
Type of Sponsor |
Other [not applicable] |
|
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 Ruchika Lulla |
Sharad Pawar Dental College |
Room No. 3
Dept. of Periodontics
PG section Wardha MAHARASHTRA |
7588752199
ruchika.lulla@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE DATTA MEGHE INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Platelet Rich Fibrin Membrane |
Multiple gingival recession defects will be treated with platelet rich fibrin membrane and patient centered outcomes will be evaluated following and during post-operative follow-up with the help of questionnare |
Comparator Agent |
Sub-epithelial connective tissue graft |
Multiple gingival recession defects will be treated with sub-epithelial connective tissue graft and patient centered outcomes will be evaluated following and during post-operative follow-up with the help of questionnaire |
|
Inclusion Criteria
|
Age From |
19.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1. Presence of multiple gingival recession (more than one) defects on the labial/ buccal surfaces of the teeth either in maxilla or mandible classified as either Miller’s Class I or II.
2. Presence of ≥ 2 mm gingival recession depth
3. Radiographic evidence of sufficient interdental bone (the distance between the crestal bone and cementoenamel junction as ≤ 2mm).
4. Presence of adequate width of keratinized gingiva apical to recession.
|
|
ExclusionCriteria |
Details |
1. Patients using tobacco products and smokers.
2. Un-cooperative patients.
3. Patients with unacceptable oral hygiene after phase I therapy and showing plaque score ≥1.
4. History of periodontal surgical treatment in quadrant selected for the study.
5. Pregnant lady or lactating mother.
6. Presence of badly caries teeth
7. Presence of mobile teeth.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Double Blind Double Dummy |
Primary Outcome
|
Outcome |
TimePoints |
Patient centered/ Subjective |
Baseline, one week, one month, 3 months and 6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
gain in CAL |
one week, one month, 3 months and 6 months |
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
27/05/2019 |
Date of Study Completion (India) |
03/12/2019 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
03/12/2019 |
Estimated Duration of Trial
|
Years="0" Months="7" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Gingival recession is exposure of the root surface due to apical migration of the gingival margin. It is a common problem in the general population and often leads the patient to seek treatment. Mucogingival therapy may be required to prevent further recession, correct esthetic problems, aid plaque control, and reduce dentin hypersensitivity. The patients today are increasingly conscious of personal appearance and much attention has been focused on denuded roots that are exposed during smiling which look unaesthetic. CAF with SCTG is accepted as the gold standard and has shown greater predictability for obtaining complete root coverage. However, the SCTG technique has some disadvantages. It is time consuming, increases morbidity, requires a second surgery, and leads to postoperative pain and bleeding, and the supply of donor tissue is limited. PRF is a second-generation platelet concentrate prepared from centrifuged blood. It is a modification of PRP and has some advantages, such as ease of preparation/application, minimal expense, and lack of biochemical modification (no bovine thrombin or anticoagulant is required). Because of PRF’s natural fibrin framework properties, growth factors can maintain their activity for a relatively longer period and effectively stimulate cell migration, wound healing, and tissue regeneration. Recent studies have demonstrated that PRF has a significant slow, sustained release of key growth factors for at least 1 week and up to 28 days, which means that PRF could stimulate its environment for a significant time during wound healing. It activates the vascular system and releases growth factors involved in soft tissue healing. The PRF membrane can be considered as an effective healing biomaterial. It features all the essential parameters permitting optimal healing. PRF membrane consists of a fibrin 3D mesh polymerized in a specific structure; the incorporation of platelets, leukocytes, and growth factors; and the presence of circulating stem cells. Furthermore, to our knowledge, only one study has tried to compare professional and patient esthetic satisfaction after root-coverage procedures. The results of this study showed that esthetic judgment of the periodontists may not always be consistent with patient satisfaction. Patients were influenced more by the soft-tissue integration variables than by the percentage of root coverage; and patients appeared to rate the cosmetic results more favorably than did the professionals. Therefore, the present study will be undertaken to compare the patient related esthetic outcome following Platelet rich fibrin (PRF) membrane with that of Sub epithelial connective tissue graft (SCTG) in Miller Class I and II multiple Gingival recession defects. |