| CTRI Number |
CTRI/2025/07/090421 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
INTERVENTION WITH CYANOACRYLATE AS ALTERNATIVE TO PROLENE 5-0 SUTURES FOR SATISFACTORY OUTCOMES AND MANAGEMENT OF ISOLATED GINGIVAL RECESSION IN MAXILLARY ANTERIOR TEETH |
|
Scientific Title of Study
|
Evaluation of effeciency of cyanoacrylate tissue adhesive versus prolene 5-0 sutures for management of isolated gingival recession with Coronally advanced flap:A Randomized controlled clinical 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 |
Lt Col Devbrat Singh |
| Designation |
PG Resident |
| Affiliation |
ARMY DENTAL CENTRE RESEARCH AND REFERRAL |
| Address |
HOD Dept of Periodontology
Army Dental Centre RR
South West
DELHI
110010
India |
| Phone |
8728042610 |
| Fax |
|
| Email |
dvbrtsingh52@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Col T Prasanth |
| Designation |
PG Guide |
| Affiliation |
Army Dental Centre Research and Referral |
| Address |
HOD Dept of Periodontology
Army Dental Centre RR
South West
DELHI
110010
India |
| Phone |
8284851155 |
| Fax |
|
| Email |
tprasanthavin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lt Col Devbrat Singh |
| Designation |
PG Resident |
| Affiliation |
Army Dental Centre Research and Referral |
| Address |
HOD Dept of Periodontology
Army Dental Centre RR
DELHI
110010
India |
| Phone |
8728042610 |
| Fax |
|
| Email |
dvbrtsingh52@gmail.com |
|
|
Source of Monetary or Material Support
|
| Army Dental Centre (R&R)
New Delhi
Pin:110010
India |
|
|
Primary Sponsor
|
| Name |
ARMY HOSPITAL RR |
| Address |
ARMY DENTAL CENTRE RR
DHAULAKUAN
NEWDELHI
110010
INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Devbrat Singh |
Dept of Periodontology, Army Dental Centre(RR) |
C Wing
Dept of Periodontology
ADC RR
South West
DELHI |
8728042610
dvbrtsingh52@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ADC(R&R) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Gingival recession on anterior maxillary teeth |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cyanoacrylate tissue adhesive |
In test group cyanoacrylate tissue adhesive will be used for stabilization of coronally advanced flap. |
| Comparator Agent |
Prolene 5-0 suture |
In control group prolene 5-0 sutures will be used for stabilization of coronally advanced flap which will be removed after 10 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Gingival recession in maxillary anterior teeth. |
|
| ExclusionCriteria |
| Details |
1.Teeth having root caries or previous restoration.
2.Surgical periodontal therapy in last 2 yrs at the involved site.
3.Past or current tobacco use.
4.Pregnant/Lactating mother.
5.Patient with a known allergy to cyanoacrylate. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Gingival recession height
Gingival recession width
Complete root coverage
Mean root coverage
To compare patient reported outcome measures. |
At baseline
At six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinician reported outcome measures in terms of time taken |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
30/07/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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 - 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
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dvbrtsingh52@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2032?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Coronally advanced flap stabilized with sutures is considered as gold standard for management of isolated gingival recession.Stabilization using sutures has its own disadvantages in terms of post op pain and discomfort to patient,time taken in placement of sutures,wicking effect caused by sutures and an additional visit to remove the sutures.Cyanoacrylate tissue adhesive provides a sutureless alternative for stabilization of coronally advanced flap along with its various advantages in the form of less application time, patient compliance,less post op pain and discomfort and its antibacterial properties .This clinical trial is being done to evaluate if cyanoacrylate can be used as an alternative to sutures for stabilization of coronally advanced flap to manage isolated gingival recession in anterior teeth |