CTRI Number |
CTRI/2020/05/024978 [Registered on: 01/05/2020] Trial Registered Prospectively |
Last Modified On: |
14/09/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Other |
Public Title of Study
|
Treatment of gingival recession using two different soft tissue graft procedures: a comparative study |
Scientific Title of Study
|
Comparative clinical evaluation of gingival unit grafts and epithelialized palatal grafts ( free gingival grafts) in the treatment of gingival recession: A randomised controlled clinical trial |
Trial Acronym |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DrNeelima Katti |
Designation |
Assistant Professor |
Affiliation |
SCB dental college and Hospital |
Address |
Department of periodontics, 3rd floor Manglabag Cuttack ORISSA 753007 India |
Phone |
09337613446 |
Fax |
|
Email |
kattineelima@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrNeelima Katti |
Designation |
Assistant Professor |
Affiliation |
SCB dental college and Hospital |
Address |
Department of periodontics, 3rd floor Manglabag Cuttack ORISSA 753007 India |
Phone |
09337613446 |
Fax |
|
Email |
kattineelima@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DrNeelima Katti |
Designation |
Assistant Professor |
Affiliation |
SCB dental college and Hospital |
Address |
Department of Periodontics, 3rd floor Manglabag Cuttack ORISSA 753007 India |
Phone |
09337613446 |
Fax |
|
Email |
kattineelima@gmail.com |
|
Source of Monetary or Material Support
|
self funding.
Dr.Neelima katti,Department of Peridontics, SCB dental College and Hospital , 3rd floor Cuttack,753007 |
|
Primary Sponsor
|
Name |
Dr Neelima Katti |
Address |
Department of Peridontics, SCB dental College and Hospital , 3rd floor Cuttack,753007 |
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 |
DrNeelima Katti |
SCB dental college and hospital |
Department of Periodontology, 3rd floor
manglabag,cuttack Cuttack ORISSA |
9337613446
kattineelima@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
institutional ethics committe (IEC), scb dental college and hospital, cuttack, odisha |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
gingival recession in mandibular teeth, belonging to Millers classification, class 1 and class 2 |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
free gingival graft |
palatal graft harvested 2mm away from adjacent gingival margin, followed up for a period of 12 months. |
Intervention |
gingival unit graft |
palatal graft involving adjacent marginal and free , followed up for a period of 12 months |
|
Inclusion Criteria
|
Age From |
18.00 Day(s) |
Age To |
60.00 Day(s) |
Gender |
Both |
Details |
Miller’s class 1 and class 2 bilateral recessions, ≥ 3mm on buccal aspects of premolars, canines and lateral incisors, in systemically healthy patients. |
|
ExclusionCriteria |
Details |
Poor oral hygiene (plaque score >20%
Smokers
Pregnancy
Root surface restorations, caries, endodontic treatment
|
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Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
percentage of root coverage achieved at the end of 12 months |
At the end of 12 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
width of keratinised gingiva
esthetic score
healing of donor site |
12 months |
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="22" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/05/2020 |
Date of Study Completion (India) |
10/03/2021 |
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
Modification(s)
|
Comparative clinical evaluation of gingival unit grafts and epithelialized palatal grafts in the treatment of gingival recession: A randomised controlled clinical trial |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kattineelima@gmail.com].
- For how long will this data be available start date provided 30-10-2021 and end date provided 30-10-2024?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Comparative clinical evaluation of gingival unit grafts and epithelialized palatal grafts ( free gingival grafts) in the treatment of gingival recession: A randomised controlled clinical trial Introduction: Gingival recession is one of the most common manifestations of periodontal diseases. The treatment modalities commonly employed to treat gingival recession sites range from free soft tissue autografts , sub epithelial connective tissue grafts, pedicle grafts, soft tissue replacement materials like collagen, alloderm, amniotic membrane etc. Epithelialized palatal grafts (EPG) more popularly known as free gingival grafts are harvested from the palate, at a distance of 2mm from the adjacent gingival margin. EPG though relies on the advantage of tissue transplant from a functionally similar site , has low predictability in its use for root coverage procedure and does not sufficiently replace the esthetics at the recipient area. Gingival unit transfer is an autogenous procedure, used in coverage of denuded roots wherein the graft harvested includes gingival margin along with the keratinised epithelium from the palate, so that the graft morphology and histology resembles the missing structures at the recipient site. The unique and complex vasculature of marginal tissue with its rich anastomosis improves the chances for graft survival on avascular root surface and increases its predictability for use in root coverage procedures. Review of literature: 1. Gingival Unit Graft Versus Free Gingival Graft for Treatment of Gingival Recession: A Randomized Controlled Clinical Trial Jenabian et al 2016 In this randomized controlled clinical trial with split mouth design, the authors concluded that gingival unit graft might be an acceptable modality in Miller Class I/II recession defects with advantages over free gingival graft such as significantly superior clinical and esthetic results. 2. Treatment of Localized Gingival Recessions Using Gingival Unit Grafts: A Randomized Controlled Clinical Trial. Kuru B, Yıldırım S 2013 The authors concluded that gingival unit grafts can be used as an alternative technique for treating buccal gingival recessions with better defect coverage, clinical, and esthetic improvements compared with palatal grafts. 3. Gingival unit transfer using in the Miller III recession defect treatment. Selin Yıldırım and Bahar Kuru 2015 In this case report the clinical effectiveness of gingival unit transfer (GUT) technique performed on Miller III recession was presented and a similar recession case treated with free gingival graft (FGG) technique for comparison. The GUT revealed better defect coverage and creeping attachment results than the FGG in the treatment of Miller III defects. 4. Use of the gingival unit transfer in soft tissue grafting: report of three cases. Allen AL 2004 The gingival unit transfer is introduced through three case reports that describe its use for root coverage and replacement of intact but pathologically involved or esthetically compromised papillae. Supracrestal gingiva, used as a free graft for the above purposes, may have an uncommon capacity for perfusion and survival. Aims and objectives: 1. To compare the use of Gingival unit transfer with epithelialized palatal graft as a surgical modality for the treatment of localised Miller’s class I and class II gingival recession defects over a six month period. 2. Justification for study Gingiva with its unique vasculature is naturally created to survive and function interproximally and facially over avascular root surfaces. Gingival unit graft, used as a free graft for recession coverage may have an uncommon capacity for perfusion and survival. More investigation is necessary to confirm the validity of this concept. Methodology: Bilateral sites in 22 patients with miller’s class 1 and class 2 recession, will be randomly assigned to recieve epithelialized palatal graft or gingival unit grafts. Plaque and gingival index will be scored at baseline after scaling, at 4 weeks and subsequently at every post surgical visit of the patient. Post surgery ,the patients will be recalled every two weeks for the first two months and once every month thereafter for six months. Recession depth, recession width, probing depth, keratinised gingiva width, clinical attachment level both at donor and recipient site will be recorded at baseline 1 month, 3 months and six months.Supra gingival polishing at each of these visits may be done as required. Potential risks & benefits: Gingival unit graft technique is relatively safer when compared to the free gingival graft as it is at a more safer distance from greater palatine artery.
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