CTRI Number |
CTRI/2019/09/021085 [Registered on: 06/09/2019] Trial Registered Prospectively |
Last Modified On: |
14/03/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
New technique for Multiple teeth Gum Recession |
Scientific Title of Study
|
COMPARISON OF A NOVEL DUAL–VESTIBULAR INCISION SUB PERIOSTEAL ACCESS TECHNIQUE (D-VISTA) WITH A CORONALLY ADVANCED MODIFIED TUNNEL ACCESS TECHNIQUE (CAMT) IN MANAGEMENT OF MULTIPLE MILLERS CLASS III GINGIVAL RECESSION -A RANDOMIZED CONTROLLED CLINICAL TRIAL. |
Trial Acronym |
D VISTA |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Santhosh Devanathan |
Designation |
Reader,Department of Periodontics |
Affiliation |
SRM Dental College , Ramapuram |
Address |
SRM Dental college,Bharathi salai, Ramapuram.
Chennai TAMIL NADU 600089 India |
Phone |
8148877084 |
Fax |
|
Email |
drsandev@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Santhosh Devanathan |
Designation |
Reader,Department of Periodontics |
Affiliation |
SRM Dental College , Ramapuram |
Address |
SRM Dental college,Bharathi salai, Ramapuram.
Chennai TAMIL NADU 600089 India |
Phone |
8148877084 |
Fax |
|
Email |
drsandev@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Muthu Kumar R |
Designation |
Post Gratuate |
Affiliation |
SRM University |
Address |
Department of Periodontics ,
SRM Dental college,Bharathi salai, Ramapuram.
Chennai TAMIL NADU 600089 India |
Phone |
09688041587 |
Fax |
|
Email |
drrmkumar@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Muthu kumar R |
Address |
2,vembuli amman kovil street,
Alandur , Chennai 16. |
Type of Sponsor |
Other [Self Funded.] |
|
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 |
Muthu Kumar R |
SRM Dental College. |
Department of Periodontics. Chennai TAMIL NADU |
09688041587
drrmkumar@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SRM Dental college Instituional Review Board |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Healthy |
Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Connective tissue graft alone. |
• Coronally advanced Modified tunnel and pouch (CAMT) with Connective tissue graft alone. |
Intervention |
D VISTA |
Vestibular incision given,Tunnel access created using VISTA Instruments,Connective Tissue Graft placed and PRF placed in papillary region.Coronally advanced and sutured . |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Both |
Details |
Subjects with Class III gingival recession
Patient with no contraindications for periodontal surgery and no history of periodontal surgery on the involved sites Subjects with Full-mouth plaque score of less than 20%; full-mouth bleeding score of less than 20% after phase 1 therapy
No occlusal interferences
|
|
ExclusionCriteria |
Details |
Patients having a Probing Pocket Depth greater than 4mm.
Sites with advance bone loss and mobility
Subjects having Non-vital teeth, teeth with restoration,
Patients undergoing orthodontic treatment
Smokers
Pregnant patients.
|
|
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 Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Depth of gingival recession
Recession width
Width of attached gingiva
Width of keratinized tissue
Percentage of root coverage
Percentage of papillary fill |
6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Percentage of papillary fill:
Measuring the height and width of papilla at baseline and 6 months post surgically.
|
6 months |
|
Target Sample Size
|
Total Sample Size="12" Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
10/09/2019 |
Date of Study Completion (India) |
10/01/2020 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Aroca S et al in 2010
C Lee et al 2015 |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Gingival recession is the exposure of the root surface resulting from the apical migration of the crest of the gingival margin. It may affect single or multiple root surfaces, posing both aesthetic and functional co-morbidities like dentinal hypersensitivity or increased predilection for developing root caries. Further the maintenance of optimal plaque control at areas with irregular gingival margins is a challenge to the patient, establishing higher risk for further periodontal breakdown. Complete coverage of the recession defect and an optimal integration of the covering tissues with the adjacent soft tissues is an essential component of periodontal therapy. Miller in 1985 proposed a classification system of which the Class III and Class IV had decreasing levels of predictability for complete root coverage. Both these categories, apart from the gingival recession over the radicular surface also had inter-proximal bone and/or soft tissue loss, or mild to severe malocclusion. This patient cohort with inter-proximal bone and soft tissue loss continues to remain the most challenging clinical situation to establish predictable root coverage over the entire denuded root surface. This clinical situation is made even worse when there is multiple teeth with gingival recessions. The current study proposal seeks to address this sub-group of Class III recessions, with gingival recessions on multiple teeth, with inter-proximal bone loss and soft tissue loss. The literature reveals only one controlled clinical trial, which addresses root coverage in this sub-group. This study by Aroca et al (2010), utilized a Modified Sub-Periosteal Tunnelling technique with connective tissue graft as described by Azzi and Etienne. The study reported a CRC percentage of 83%. The current study proposes to utilize an amalgamation of the VISTA technique and the Coronally Advanced Modified Tunnel Technique (CAMT), the modified VISTA (m-VISTA). This technique proposes to utilize a sub-periosteal tunnelling through a vestibular access and a contiguous crevicular access, which will establish a facial sub-periosteal tunnel along with a trans-papillary tunnel, enabling space provision and coronal advancement. Further the technique envisages the utilization of a dual grafting of connective tissue graft over the radicular surface and a L-PRF matrix in the interproximal region, to maximize the capacities of the grafts in these two unique anatomical regions, to synergize the ability to establish root coverage in this complex gingival recession defect. We introduce this access as the Dual-VISTA Technique (D-VISTA). The connective tissue graft has long been identified as the gold standard for root coverage, when utilized with an access that would provide a bi laminar blood supply to this graft, while it heals over the avascular root surface, as identified through multiple review articles and meta-analysis (Cairo et al.2014, Tatakis et al.2015). However the utilization of the connective tissue graft to augment the dental papilla, without splitting the papilla is a surgical challenge due to the narrowness of the gingival embrasure space. Further such a connective tissue graft that is tunnelled across the papilla has greater chance of graft strangulation that would therefore compromise graft viability and its ability to augment the interdental gingiva. Therefore the dual grafting that is proposed, seeks to address the peculiar grafting needs in the different zones that present with gingival recession. The L-PRF matrix across the inter-dental gingiva has the ability to remain a viable graft despite the constriction of the graft and compromised vascular supply following the sub-periosteal trans papillary dissection. It would serve to note that the PRF matrix has been proven to be a viable autologous matrix in the augmentation of gingival width and thickness, as well as in the coverage of gingival recession defects as has been previously reported by Aroca S et al in 2009 and Oncu E 2017. This study is being proposed as split mouth randomized controlled trial, to compare the efficacy of the proposed D-VISTA technique, as compared to a control group managed by CAMT technique in the management of multiple Class III gingival recessions. |