| CTRI Number |
CTRI/2020/03/024238 [Registered on: 25/03/2020] Trial Registered Prospectively |
| Last Modified On: |
12/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of receding gums with two different techniques in smokers |
|
Scientific Title of Study
|
Evaluation of root coverage using collagen matrix (Mucograftâ„¢)and sub epithelial connective tissue graft (SCTG) with modified coronally advanced tunnel technique (MCAT) in the treatment of multiple gingival recessions in smokers-A prospective randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NVS Sruthima G |
| Designation |
Professor |
| Affiliation |
vishnu dental college |
| Address |
Block 2
room no 7
Department of periodonntics and implantology
vishnu dental college
vishnupu
Block 2
room no 7
Department of periodonntics and implantology
vishnu dental college
vishnupu
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9492293808 |
| Fax |
|
| Email |
sruthima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NVS Sruthima G |
| Designation |
Professor |
| Affiliation |
vishnu dental college |
| Address |
Block 2
room no 7
Department of periodonntics and implantology
vishnu dental college
vishnupu
Block 2
room no 7
Department of periodonntics and implantology
vishnu dental college
vishnupu
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9492293808 |
| Fax |
|
| Email |
sruthima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M Rajya Lakshmi |
| Designation |
Student |
| Affiliation |
vishnu dental college |
| Address |
Block 2
room no 7
Department of periodonntics and implantology
vishnu dental college
vishnupu
Block 2
room no 7
Department of periodonntics and implantology
vishnu dental college
vishnupu
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9441952538 |
| Fax |
|
| Email |
rajimikkili123@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NVS Sruthima G |
| Address |
Block 2
room no 7
Department of periodontics and implantology
vishnu dental college
vishnupur |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| NVS Sruthima G |
Vishnu dental college |
room no.7
block 2
department of periodontics
West Godavari
ANDHRA PRADESH |
9492293808
sruthima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vishnu Dental College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mucograftâ„¢ |
Modified Coronally advanced Tunnel technique alog with Mucograftâ„¢ in treatment for gingival recessions in smokers |
| Comparator Agent |
Sub epithelial connective tissue graft |
Modified Coronally advanced Tunnel technique along with Sub epithelial connective tissue graft in smokers |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. Patients aged between 18 to 60 years
2. Smokers who smoke on an average of ≥ 5 Cigarettes per day
3. Systemically Healthy with no contraindications for periodontal surgery
4. Presence of ≥ 2 adjacent Millers Class I and Class II Recessions
5. Absence of clinical signs of active periodontal disease.
|
|
| ExclusionCriteria |
| Details |
1. Malpoistioned teeth
2. Active (or) untreated gingival and periodontal disease
3. Any systemic conditions that would interfere with healing
4. Pregnant or lactating women
5. Patients treated with any medication known to affect the gingival condition.
6. Patients who are not willing to comply with smoking cessation protocol.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Amount of root coverage in terms of width and depth (Relative Attachement Level)
Increase in the width of Keratinized Gingiva
Improvement in Gingival Biotype
Percentage of root coverage
Time taken for the procedure
Patient Morbidity using Visual Analogue Scale. ( Discomfort, Dentinal Hypersensitivity)
|
Baseline
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of root coverage |
6 months |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
| The challenge for periodontal plastic surgical procedures is to achieve stable and complete root coverage with an attachment of the tissue margin at the CEJ as well as to increase the dimensions, i.e., thickness and width of keratinized gingiva and to maintain healthy gingival sulcus. A variety of surgical techniques such as laterally positioned pedicle graft, free gingival graft, subepithelial connective tissue graft (SCTG), coronally advanced flap, guided tissue regeneration along with biologic mediators like platelet rich fibrin (PRF) etc. have been evaluated in the last few decades to obtain root coverage with predictability and consistency for Multiple Adjacent Gingival Recession. SCTG is considered as a gold standard. However, longer surgical time and an increase in patient morbidity in the treatment of multiple adjacent gingival recessions using SCTG have become a challenge to both clinician and patient. To overcome the drawbacks of patient morbidity during harvest of SCTG other alternatives such as Allografts and Guided tissue regeneration are available but have their own limitations. One such newly developed alternative is a porcine-derived collagen matrix.The Mucograftâ„¢ was introduced by Giestlich company. Determinants of a successful root coverage procedure include operative technique, defect characteristics, and patient attributes. Among the patient-related factors, cigarette smoking is known to negatively influence the healing outcome following periodontal surgical procedures, including grafting for root coverage. The main aim of this prospective randomized controlled clinical trial is to evaluate the outcome of root coverage with Collagen Matrix (Mucograftâ„¢ ) and SCTG using the MCAT technique in smokers. parameters are Amount of root coverage in terms of width and depth Increase in the width and thickness of Keratinized Gingivitis Percentage of root coverage Patient Morbidity using Visual Analogue Scale. ( pain, Dentinal Hypersensitivity)
| |