| CTRI Number |
CTRI/2016/05/006921 [Registered on: 11/05/2016] Trial Registered Retrospectively |
| Last Modified On: |
04/05/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two procedures for the treatment of exposed root surfaces in teeth |
|
Scientific Title of Study
|
Treatment of multiple gingival recessions - Coronally advanced flap without vertical releasing incisions versus modified semilunar coronally advanced flap: A clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Venkatesan |
| Designation |
Post graduate |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Manipal College of Dental Sciences,
Light house hill road, Hampankatta. Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9444868848 |
| Fax |
|
| Email |
dentistvenkatesan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashita Uppoor |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Manipal College of Dental Sciences,
Light house hill road, Hampankatta. Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
|
| Fax |
|
| Email |
ashita.uppoor@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ashita Uppoor |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Manipal College of Dental Sciences,
Light house hill road, Hampankatta. Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
|
| Fax |
|
| Email |
ashita.uppoor@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Venkatesan |
| Address |
DEPARTMENT OF PERIODONTOLOGY,MANIPAL COLLEGE OF DENTAL SCIENCES,LIGHT HOUSE HILL ROAD,HAMPANKATTA, MANGALORE |
| Type of Sponsor |
Other [Venkatesan] |
|
|
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 |
| VENKATESAN |
MANIPAL COLLEGE OF DENTAL SCIENCES, MANGALORE |
DEPARTMENT OF PERIODONTOLOGY,ROOM NUMBER 4 MANIPAL COLLEGE OF DENTAL SCIENCES, LIGHT HOUSE HILL ROAD , HAMPANKATTA, MANGALORE 575001
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
9444868848
dentistvenkatesan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICALCOOMMITTEE, MANIPAL COLLEGE OF DENTAL SCIENCES, MANGALORE |
Approved |
| Institutional ethics committee, Manipal college of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Multiple adjacent Gingival recession, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CORONALLY ADVANCED FLAP WITHOUT VERTICAL RELEASING
INCISIONS |
Submarginal incisiwithout vertical releasing incisionsons with split thickness |
| Intervention |
MODIFIED SEMILUNAR CORONALLY ADVANCED FLAP |
Semilunar incision with partial thgickness intrasulcular incision |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Presence of bilateral maxillary
Miller’s Class I adjacent gingival recessions ≥2mm, Difference in depth of the gingival
recessions between the right & left side ≤1mm & difference in clinical attachment ≤2mm,
Probing depth less than 3mm & full mouth plaque index score <20%, full mouth gingival
index score <20%,Cervical abrasion, caries, grooves in areas of gingival recession were treated |
|
| ExclusionCriteria |
| Details |
untreated periodontal disease, smokers, subjects with immunocompromised disease, Current pregnancy or lactation,
Patient with unjustified absence for scheduled visits, continued traumatic tooth brushing,
faulty plaque control measures. subjects with malaligned teeth |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| RECESSION HEIGHT,RECESSION WIDTH,PROBING DEPTH,CLINICAL ATTACHMENT LEVEL,WIDTH OF KERATINIZED GINGIVA,GINGIVAL THICKNESS,MEAN ROOT COVERAGE,PERCENTAGE OF COMPLETE ROOT COVERAGE |
BASELINE AND 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient evaluation of esthetics- VAS score |
BASELINE AND 6 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NOT SENT FOR PUBLICATION |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THE OBJECTIVE OF THE PRESENT STUDY WAS TO COMPARE CLINICAL OUTCOME OF TWO CORONALLY ADVANCED FLAP WITHOUT VERTICAL RELEASING INCISIONS AND MODIFIED SEMILUNAR CORONALLY ADVANCED FLAP AND TO EVALUATE PATIENT CENTRED OUTCOME FOR BOTH THE PROCEDURE USING VISUAL ANALOGUE SCALE. THE STUDY INVOLVED 10 PATIENTS WITH BILATERAL RECESSIONS(MILLER’S CLASS 1) OF BOTH GENDERS.CLINICAL PRAMETERS WHICH WERE EVALUATED CONSISTED OF RECESSION HEIGHT, RECESSION WIDTH, WITH OF KERATINIZED GINGIVA, CLINICAL ATTACHMENT LEVEL, PROBING DEPTH, FULL MOUTH PLAQUE AND GINGIVAL SCORES. PATINTERED OUTCOME INCLUDED ESTHETIC SCORE (VISUAL ANALOGE SCALE).THE PARAMETERS WERE ASSESSED AT BASELINE AND 6 MONTHS. |