| CTRI Number |
CTRI/2022/12/048035 [Registered on: 12/12/2022] Trial Registered Prospectively |
| Last Modified On: |
31/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study effect of bio-glue in patients for the closure of wounds following oral surgery. |
|
Scientific Title of Study
|
Efficacy of cyanoacrylate tissue adhesive for intraoral wound closure: a prospective study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr kanishk Srivastava |
| Designation |
Post Graduate Trainee |
| Affiliation |
Dr.M.G.R. Educational and Research Institute |
| Address |
Department of oral and maxillofacial Surgery, Thai Moogambigai Dental College and Hospital,Gangai Amman Koil St, Golden George Nagar, Mogappair, Chennai, Tamil Nadu 600107
Chennai
TAMIL NADU
600107
India |
| Phone |
8762051995 |
| Fax |
|
| Email |
kanishk013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Senthil K Kumar |
| Designation |
Professor |
| Affiliation |
Dr.M.G.R. Educational and Research Institute |
| Address |
Department of oral and maxillofacial Surgery, Thai Moogambigai Dental College and Hospital,Gangai Amman Koil St, Golden George Nagar, Mogappair, Chennai, Tamil Nadu 600107
Chennai
TAMIL NADU
600107
India |
| Phone |
9884634754 |
| Fax |
|
| Email |
senthilomfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Senthil K Kumar |
| Designation |
Professor |
| Affiliation |
Dr.M.G.R. Educational and Research Institute |
| Address |
Department of oral and maxillofacial Surgery, Thai Moogambigai Dental College and Hospital,Gangai Amman Koil St, Golden George Nagar, Mogappair, Chennai, Tamil Nadu 600107
Chennai
TAMIL NADU
600107
India |
| Phone |
9884634754 |
| Fax |
|
| Email |
senthilomfs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Thai Moogambigai Dental College and Hospital,
Constituent Unit of Dr.M.G.R. Educational and Research Institute, Gangai Amman Koil St, Golden George Nagar, Mogappair, Chennai, Tamil Nadu 600107 |
|
|
Primary Sponsor
|
| Name |
Dr Kanishk Srivastava |
| Address |
Department of oral and maxillofacial surgery, Thai Moogambigai Dental College and Hospital, Gangai Amman Koil St, Golden George Nagar, Mogappair, Chennai, Tamil Nadu 600107 |
| 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 |
| Dr Kanishk Srivastava |
Thai Moogambigai Dental College and Hospital |
Department of Oral and Maxillofacial Surgery, P.G. Clinic, F-202, Gangai Amman Koil St., Golden George Nagar, Mogappair, Chennai, Tamil Nadu 600107
Chennai
TAMIL NADU |
8762051995
kanishk013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.M.G.R. Educational and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, (2) ICD-10 Condition: K116||Mucocele of salivary gland, (3) ICD-10 Condition: K136||Irritative hyperplasia of oral mucosa, (4) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, (5) ICD-10 Condition: K041||Necrosis of pulp, (6) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
n-butyl and 2-octyl cyanoacrylates(PeriAcryl 90 High Viscosity, GluStitch) |
Commercially available synthetic tissue adhesive applied using a pipette.
Duration of intervention : 3 minutes |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with the age 18 years and above will be selected for the study.
2.Minor oral surgical procedures were closure of intra oral surgical incisions are required
3.Procedures like, multiple extractions, canine exposure, transalveolar extractions, surgical extraction of impacted third molars and canine, alveoloplasty, biopsy, and excision of mucocele are included in the study.
4.Clean incisions which can be approximated without tension are included.
5.Patient who agreed to follow the study protocol. |
|
| ExclusionCriteria |
| Details |
Patients will not be considered for the study with the following criteria:
1.Immunocompromised patients.
2.Uncontrolled diabetes
3.Bleeding disorders
4.Uncooperative patients
5.Neurological disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improved and early wound healing of test site |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of tissue adhesive for early wound healing of the surgical site, healing will be much better and patients compliance will be more towards the product under investigation. |
3rd and 7th day post op. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/12/2022 |
| Date of Study Completion (India) |
31/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In the study we are going evaluate the
clinical post-operative healing after the use of cyanoacrylate tissue adhesive
in intraoral wound closure. The employed tissue adhesive is PeriAcryl
90 High Viscosity (GluStitch), it is a blend a of n-butyl and 2-octyl
cyanoacrylate. It is a violet colour liquid monomer packed in a container that
polymerizes on contact with aqueous-containing substances (Hydroxyl ions), such
as blood and moisture, it sets within 5 to 10 seconds. Cyanoacrylate
tissue adhesive is biocompatible material and takes about 7 - 10 days to slough
off the mucosa after application.
|