| CTRI Number |
CTRI/2024/07/069807 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the amount of root coverage in receded gums after using two different materials |
|
Scientific Title of Study
|
Comparative clinical evaluation of sub epithelial connective tissue graft SCTG and xenogenic collagen matrix in treatment of Miller s class I and class II gingival recession A randomized split mouth control trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinitha V |
| Designation |
Post graduate student in department of Periodontology and Oral Implantology |
| Affiliation |
Government dental college and hospital |
| Address |
Department of Periodontology and Oral implantology,Government dental college and hospital,Rajbandha,Maidan Path,Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9791305137 |
| Fax |
|
| Email |
vinithabds28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineeta Gupta |
| Designation |
Head of the department |
| Affiliation |
Government dental college and hospital |
| Address |
Department of periodontology and oral implantology,Government dental college and hospital,Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9791305137 |
| Fax |
|
| Email |
vinleo76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinitha V |
| Designation |
Head of the department |
| Affiliation |
Government dental college and hospital |
| Address |
Department of Periodontology and Oral implantology,Government dental college and hospital,Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9791305137 |
| Fax |
|
| Email |
vinithabds28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college and hospital,Rajbandha,Maidan Path,Raipur,Chhattisgarh,India,492001 |
|
|
Primary Sponsor
|
| Name |
Vinitha V |
| Address |
Government dental college and hospital,Rajbandha,Maidan Path,Raipur,Chhattisgarh,India,492001 |
| 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 |
| Dr Vinitha V |
Government dental college and hospital |
Room no 12,Department of Periodontology
Raipur
CHHATTISGARH |
9791305137
vinithabds28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Human Studies,Government dental college,Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
sub epithelial connective tissue graft |
Patients will be treated with sub epithelial connective tissue graft by coronally advanced flap technique depending upon the depth of recession on the control site and the total duration is 18 months |
| Intervention |
xenogenic collagen matrix |
Patients will be treated with xenogenic collagen matrix by coronally advanced flap technique depending upon the depth of recession on the test site and the total duration is 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with age of ≥18 years
2 Patients have to display at least one buccal recession(bilaterally) classified as Miller s class I or II with no visible loss of interdental hard and soft tissues
3 Probing pocket depth <3mm
4 No prior history of any surgical procedures on the site to be treated
5 Presence of detectable CEJ
6 Systemically healthy subjects with no contraindication to periodontal surgery
7 Able to achieve good oral hygiene and control gingivitis in the whole of the dentition
8 Patient willing to undergo surgical procedure with written informed consent
9 No permanent medication in the last 6 months |
|
| ExclusionCriteria |
| Details |
1 Persistence of uncorrected gingival trauma from tooth brushing
2 Presence of severe tooth malposition rotation or clinically significant supra-eruption
3 Cervical or root caries cervical abrasion prosthetic crown and restorations involving cemento-enamel junction
4 Pregnant and lactating mothers
5 Hypersensitivity or allergy to the collagen based medical product
6 Patients using smoked and smokeless form of tobacco for atleast 6 months |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Is to evaluate the amount of root coverage using sub epithelial connective tissue graft and xenogeneic collagen matrix at 3 and 6 months |
3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patients will be evaluated for recession width keratinized tissue thickness keratinized tissue height |
one year |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "17"
Final Enrollment numbers achieved (India)="17" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/08/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A randomized split mouth study will be conducted for a duration of 18 months for the treatment of Miller s class I and class II gingival recession cases. The randomization will be based on coin toss method. The control site will be treated with sub epithelial connective tissue graft, whereas the test site will be treated with xenogenic collagen matrix. Coronally advanced flap technique will be used for placing both the materials.The primary outcome of this study is to evaluate the amount of root coverage. The secondary outcome is to evaluate the long term success , including other parameters like recession depth, probing pocket depth, recession width and keratinized tissue thickness.The duration for the evaluation of these parameters are 0,3 months and 6 months.In
terms of traditional measures of root coverage, at 3 months, XCM+CAF achieved 97.35
± 7.52
PRC, compared to 95.88 ± 9.23 PRC for CTG+CAF and at 6
months, 100 % was achieved respectively. Thus, CM+CAF presents an intriguing
comparison to the traditional CTG gold standard, in terms of colour matching,
texture and healing. The
principal findings of the present study were reduction in RW, RD, PPD, RAL and
VAS score, gain in KTH, KTT and PRC in both the groups after 3 and 6 months. RCES
was not significant in XCM and SCTG group. Time take for surgery and pain
perception after surgery were less in XCM group as compared to SCTG group. |