| CTRI Number |
CTRI/2020/12/030104 [Registered on: 29/12/2020] Trial Registered Prospectively |
| Last Modified On: |
15/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing cyanoacrylate tissue adhesives and absorbable sutures in donor sites of connective tissue grafts (CTG) for primary closure. |
|
Scientific Title of Study
|
Comparison between cyanoacrylate tissue adhesives and absorbable sutures in the primary closure of donor sites of connective tissue grafts. – A Randomized 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 Dipika Mitra |
| Designation |
Professor and HOD |
| Affiliation |
Terna Dental College and Hospital. |
| Address |
Terna Dental College and Hospital Plot no. 12, Sector 22, Opp Nerul West Railway Station, Nerul West, Navi Mumbai, Maharashtra.
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9820180406 |
| Fax |
|
| Email |
drdipikamitra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipika Mitra |
| Designation |
Professor and HOD |
| Affiliation |
Terna Dental College and Hospital. |
| Address |
Terna Dental College and Hospital Plot no. 12, Sector 22, Opp Nerul West Railway Station, Nerul West, Navi Mumbai, Maharashtra.
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9820180406 |
| Fax |
|
| Email |
drdipikamitra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kashmira Ghangrekar |
| Designation |
Post Graduate Student |
| Affiliation |
Terna Dental College and Hospital |
| Address |
Terna Dental College and Hospital Plot no. 12, Sector 22, Opp Nerul West Railway Station, Nerul West, Navi Mumbai, Maharashtra.
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9930660555 |
| Fax |
|
| Email |
kashmira.ghangrekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, Terna Detal College and hospital, Nerul, Navi Mumbai, India |
|
|
Primary Sponsor
|
| Name |
Terna Dental College |
| Address |
Terna Dental College and Hospital Plot No. 12, Sector 22, Opp.
Nerul West Railway Station, Nerul
|
| Type of Sponsor |
Other [private dental college.] |
|
|
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 Kashmira Ghangrekar |
TPCTs Terna Dental College |
Department of
periodontics, room no.
103, Plot No. 12,
Sector–22, Opp. Nerul
West Railway Station,
Nerul West, Navi
Mumbai, Maharashtra
400706 Mumbai
MAHARASHTRA
Thane
MAHARASHTRA |
9930660555
kashmira.ghangrekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Terna Dental College Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy individuals with miller’s Class I and Class II recession needing recession
coverage. |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Absorbable
sutures in primary closure of donor sites of connective tissue grafts (CTG) |
Absorbable
sutures in primary closure of donor sites of connective tissue grafts (CTG). Depending upon the incision length 7-10 sutures placed over a period of 8-10 minutes |
| Intervention |
cyanoacrylate tissue adhesive in primary closure of donor sites of connective tissue grafts (CTG) |
cyanoacrylate tissue adhesive in primary closure of donor sites of connective tissue grafts (CTG). 3-4 LAYERS of glue for over a period of 1 minute |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Full Mouth Plaque Score and Full Mouth Bleeding Score needed to
be <20%
2. Patients with miller’s Class I and Class II recession needing recession
coverage.
3. Patients between the age group of 18 – 60 yrs.
4. Patients maintaining good oral hygiene.
5. Systemically healthy patients.
6. Patients who give informed consent to participate in the study.
7. Patients who do not consume tobacco in any form. |
|
| ExclusionCriteria |
| Details |
1. Patients who have undergone any periodontal surgical therapy in
the last 6 months in the same site.
2. Patients taking anticoagulants and anti-platelet drugs
3. Patients with allergies to materials used in treatment process.
4. Pregnant and lactating females.
5. Patients with coagulation disorders (e.g. Hemophilia a/b, von
Willebrand disease, liver disease)
6. Patients on corticosteroids.
7. Patients with a history of contact dermatitis to formaldehyde.
8. Patients who have uncontrolled diabetes.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure and compare primary wound closure at palatal donor
area in patients undergoing sub-epithelial connective tissue grafts (CTG)
between cyanoacrylates tissue adhesives and absorbable suture. |
Baseline
1 day
7 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To measure and compare the time taken for wound closure, Early Wound
Healing Index and Patient pain and discomfort at palatal donor area of
sub-epithelial connective tissue grafts (CTG) between cyanoacrylates tissue
adhesives and absorbable suture using Visual Analogue Score (VAS) |
Baseline
1 day
7 day |
|
|
Target Sample Size
|
Total Sample Size="8"
Sample Size from India="8"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
04/01/2021 |
| Date of Study Completion (India) |
28/01/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Randomised Clinical Trial to compare between cyanoacrylate tissue adhesives and absorbable
sutures in primary closure of donor sites of connective tissue grafts (CTG) that will
be conducted in Terna Dental College, India. The primary outcome will be
to measure primary wound closure at palatal donor
area in patients undergoing sub-epithelial connective tissue grafts (CTG). |