| CTRI Number |
CTRI/2024/06/068416 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Multiple gum recession treatment using tunnel technique by comparing two different graft harvesting methods |
|
Scientific Title of Study
|
De-epithelialized Free Gingival Graft Versus Subepithelial Connective
Tissue Graft in the treatment of multiple adjacent gingival recessions
using Modified Coronally Advanced Tunnel Technique: A Randomized
Controlled Trial. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nihal Devkar |
| Designation |
Professor |
| Affiliation |
Sinhgad Dental College and Hospital, Pune |
| Address |
Department of periodontology, room no. 4, Sinhgad Dental College and Hospital, Vadgaon Budruk, Off
Sinhgad Road, Pune-411041
Pune
MAHARASHTRA
411041
India |
| Phone |
9420481441 |
| Fax |
|
| Email |
drdevkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nihal Devkar |
| Designation |
Professor |
| Affiliation |
Sinhgad Dental College and Hospital, Pune |
| Address |
Department of Periodontology, room no. 4, Sinhgad Dental College and Hospital, Vadgaon Budruk, Off
Sinhgad Road, Pune-411041
MAHARASHTRA
411041
India |
| Phone |
9420481441 |
| Fax |
|
| Email |
drdevkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nihal Devkar |
| Designation |
Professor |
| Affiliation |
Sinhgad Dental College and Hospital, Pune |
| Address |
Department of periodontology, room no. 4, Sinhgad Dental College and Hospital, Vadgaon Budruk, Off
Sinhgad Road, Pune-411041
MAHARASHTRA
411041
India |
| Phone |
9420481441 |
| Fax |
|
| Email |
drdevkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sinhgad Dental College and Hospital, S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041, India |
|
|
Primary Sponsor
|
| Name |
Dr Snehal Pudke |
| Address |
S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041 |
| 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 Snehal Pudke |
Sinhgad Dental College And Hospital, Pune |
Department of periodontology, room no. 4, sinhgad Dental College and Hospital, S No 44 1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra
Pune
MAHARASHTRA |
8600696344
snehalpudke07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sinhgad Dental College and Hospital |
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 |
De-epithelialized free gingival graft |
De-epithelialized Free Gingival Graft in the treatment of multiple adjacent gingival recessions using
Modified Coronally Advanced Tunnel Technique and assessment after 6 months |
| Comparator Agent |
Subepithelial connective tissue graft |
Subepithelial Connective
Tissue Graft in the treatment of multiple adjacent gingival recessions using
Modified Coronally Advanced Tunnel Technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy patients with age between 18 and 60 yrs.
2. At least 20 natural teeth should be present.
3. At least two adjacent Millers class I and II or Cairo’s RT1
recession defects from 2nd premolar right side to 2nd premolar left
side in maxillary and mandibular arches.
4. Minimum depth of gingival recession defect should be ≥ 2mm.
5. Patients with healthy periodontal conditions.
6. Patients with esthetic concerns.
7. Patients willing to participate and willing to sign an informed
consent. |
|
| ExclusionCriteria |
| Details |
1. Systemic conditions and diseases that could affect the
progression of periodontal disease.
2. Patients those who underwent any subgingival periodontal
therapy or antibiotic therapy in past 6 months.
3. Patients using smokeless as well as smoking form of tobacco.
4. Pregnant and lactating females. |
|
|
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 |
To compare the complete/extent of root coverage
(CRC) percentage in multiple adjacent gingival recessions (Millers class I
and II or Cairo’s RT1) at baseline and 6 months after surgery using MCAT
technique with de-epithelialized FGG and MCAT with SCTG |
Baseline and 6 months after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare clinical parameters like Mean root
coverage (MRC) , Keratinized tissue width (KTW), Gingival recession depth
(RD), Gingival recession width (RW) and width of attached gingiva (WAG)
in multiple adjacent gingival recessions (Millers class I and II or Cairo’s
RT1) at baseline and 6 months after surgery using MCAT technique with
de-epithelialized FGG and MCAT with SCTG.
|
1 month, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="19"
Sample Size from India="19"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/07/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gingival recession is the exposure of the root surface resulting from migration of the gingival margin apical to the cementoenamel junction (CEJ).Multiple adjacent gingival recession(MAGR) is common and various techniques have been described for the its treatment [e.g., coronally advanced flap (CAF), tunnel technique (TUN), flap designs (e.g., CAF with/without vertical releasing incisions, TUN with/without split-flap, etc.), adjuncts [e.g., free gingival graft (FGG), connective tissue graft (CTG), enamel matrix derivatives (EMD), soft tissue substitutes (STS) membranes for guided tissue regeneration (GTR), etc.], and combinations thereof have been tried. Most systematic reviews conclude that CAF + CTG should be considered as the ‘gold standard’ for single Miller class I and II GR, also coined as recession type (RT1). Recent literature indicate that tunnel technique (TUN) is a highly effective and predictable procedure in the treatment of multiple Gingival Recession (GR) defects. Positive outcomes of root coverage with TUN might be attributed to inherent advantage of this approach being a minimally invasive procedure with limited flap opening and lack of vertical releasing incisions, all of which contribute to decreased tissue trauma, enhanced wound healing, and greater blood supply to the graft. (Azzi & Etienne 1998, Zuhr et al. 2007, Aroca et al. 2010). Tunnel technique was first introduced by Allen in 1994, and its modifications by Zabalegui in 1999, Modified Coronally Advanced Tunnel (MCAT) by Azzi et al 2002 and Microsurgical CAT by Zuhr 2007. Over the following years, additional modifications of MCAT technique were proposed, such as introduction of the microsurgical approach, full-thickness flap preparation, papillae detachment and elevation, modified suturing technique, application of collagen porcine dermal matrix in lieu of SCTG , inclusion of biological factors such as enamel matrix derivative (EMD) or concentrated growth factor (CGF) , and site-specific application of Sub-epithelial connective tissue graft (SCTG). Various techniques have been proposed to obtain SCTG. Recently, de-epithelialized free gingival graft (FGG) has been used as another method to obtain SCTG. Therefore, the aim of this split mouth randomized controlled study is to evaluate and compare de-epithelialized FGG or SCTG in the treatment of multiple adjacent gingival recessions using MCAT. |