| CTRI Number |
CTRI/2022/11/047783 [Registered on: 30/11/2022] Trial Registered Prospectively |
| Last Modified On: |
30/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Treatment of receding gums using two different material. |
|
Scientific Title of Study
|
clinical outcomes of modified coronally advanced tunnel technique using sub-epithelial connective tissue graft , xenogenic collagen matrix (XCM) and XCM with injectable platelet rich fibrin in the treatment of RT1 gingival recession : A three arm randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Supriya Mishra |
| Designation |
consultant |
| Affiliation |
Government Dental College , Raipur |
| Address |
Department of periodontics, GDC Raipur
Raipur CHHATTISGARH 492001 India |
| Phone |
|
| Fax |
|
| Email |
dr.supriya4@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Supriya Mishra |
| Designation |
consultant |
| Affiliation |
Government Dental College , Raipur |
| Address |
Department of periodontics, GDC Raipur
Raipur CHHATTISGARH 492001 India |
| Phone |
|
| Fax |
|
| Email |
dr.supriya4@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Supriya Mishra |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College , Raipur |
| Address |
Department of Periodontics, GDC raipur
Raipur CHHATTISGARH 492001 India |
| Phone |
|
| Fax |
|
| Email |
dr.supriya4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhilai dental clinic and Hospital |
|
|
Primary Sponsor
|
| Name |
other |
| Address |
bhilai dental clinic, sector 4 bhilai |
| Type of Sponsor |
Other [clinician] |
|
|
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 Supriya Mishra |
bhilai dental clinic |
sector 4, bhilai Durg CHHATTISGARH |
8889651606
dr.supriya4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, maitri college of dentistry and research center, anjora, durg |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
gingival recession |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
modified coronally advanced tunnel technique with i-prf and xenogenic collagen matrix |
modified coronally advanced tunnel technique with i-prf and xenogenic collagen matrix in the treatment of gingival recession |
| Comparator Agent |
modified coronally advanced tunnel technique with xenogenic collagen matrix alone and SCTG |
modified coronally advanced tunnel technique with xenogenic collagen matrix alone and Sub epithelial connective tissue graft |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patient with age of ≥18 years.
Presence of bilateral Miller’s class I (Marginal tissue recession, which does not extend to the mucogingival junction (MGJ)) / class II (Marginal tissue recession extending to or beyond mucogingival junction(MGJ)) gingival recession of same depth on buccal aspect of anterior teeth and premolars with no radiographic sign of bone loss and requiring surgical intervention for root coverage,
Probing pocket depth <3mm,
No prior history of any surgical procedures on the site to be treated,
Presence of detectable CEJ,
Not using tobacco in any form,
Systemically healthy subjects with no contraindication to periodontal surgery,
Able to achieve good oral hygiene and control gingivitis in the whole of the dentition (FMPS<10% and FMBS<10%)
Patient willing to undergo surgical procedure and giving written informed consent
|
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| modified Coronally advanced tunnel flap with xenogeneic collagen matrix (XCM) and i-prfto be similarly effective as coronally advanced flap with sub-epithelial connective tissue graft (SCTG) in root coverage procedures in terms of recession depth (RD) and percentage root coverage (RC) at baseline, 1 week, 6 months |
modified Coronally advanced tunnel flap with xenogeneic collagen matrix (XCM) and i-prfto be similarly effective as coronally advanced flap with sub-epithelial connective tissue graft (SCTG) in root coverage procedures in terms of recession depth (RD) and percentage root coverage (RC) at baseline, 1 week, 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| relative attachment level, keratinized tissue height, keratinized tissue thickness , recession width and root coverage esthetic score in patients treated with XCM and iprf when compared to patients treated with SCTG and XCM only |
at 6 months |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2022 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There are various surgical techniques and their modifications for the treatment of gingival recession. These include pedicle grafts (lateral sliding or double papillae) with or without connective tissue grafts, epithelised autogenous grafts (free gingival), sub-epithelial connective tissue grafts (SCTG), coronally advanced flaps (CAF) alone, CAF preceded by a free gingival graft, and CAF with a simultaneous SCTG. SCTG helps in improved long-term stability of complete root coverage (CRC) and it is accepted as the gold standard in the treatment of gingival recessions. However, the requirement of a second surgical site, limited amount of graft, rather low patient tolerance and high complication rates in donor area are the major disadvantages of SCTG. To reduce these disadvantages, barrier membrane, platelet-rich plasma, platelet-rich fibrin, enamel matrix derivatives and graft substitute materials have been used as an alternative to SCTG. But studies have shown that only SCTG in conjunction with CAF was able to enhance the ability to achieve complete root coverage and to improve recession reduction. Human acellular dermal matrix (ADM) was introduced as SCTG substitute with various surgical techniques aiming root coverage but no additional benefit over CAF+SCTG was found. Additionally, there is a possible risk for disease transmission as it is derived from cadavers which limited the use of this material. Recently, a new bi-layer xenogeneic collagen matrix (XCM) has been used in periodontal regenerative procedures. XCM is composed of a cell occlusive layer with compact collagen fibre and a spongious layer with porous collagen structure. This porous layer provides stabilization of blood clot and necessary space that helps in cell migration and might increase the formation of keratinized tissue. Hence, XCM seems to be a promising soft tissue graft substitute when used with CAF. It is not only less invasive and time consuming but also provides unlimited off-the-shelf supply of graft material and has been cleared by U S Food and Drug Administration (FDA). Injectable platelet-rich fibrin (i-PRF) has been produced by changing the type of the tube, centrifugation time and speed; specifically, the blood is centrifuged in plastic tubes at 700 rpm for 3 min (Miron & Choukroun, 2017). I-PRF prepared according to low-speed centrifugation concept can provide a significant advantage for the regeneration process, as it is rich in platelets, leucocytes and growth factors (Choukroun & Ghanaati,2018). |