| CTRI Number |
CTRI/2024/12/078045 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the efficacy of 3-0 silk suture material versus N-butyl 2 cyanoacrylate glue in intra-oral soft tissue closure in alveoloplasty |
|
Scientific Title of Study
|
Evaluation of efficacy of n-butyl 2 cyanoacrylate in intra-oral soft tissue closure in alveoloplasty: Clinical split-mouth comparative study |
| Trial Acronym |
ALVBUT1 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 041/2024-2025 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simran Arawattigi |
| Designation |
Intern |
| Affiliation |
Krishna Vishwa Vidyapeeth, Karad |
| Address |
Krishna Vishwa Vidyapeeth, Karad, Maharashtra
OPD no. 24, Second floor, Department of Oral and Maxillofacial Surgery, School of Dental Sciences, Krishna Vishwa Vidyapeeth, Karad, Maharashtra
Satara
MAHARASHTRA
415539
India |
| Phone |
7083305744 |
| Fax |
7083305744 |
| Email |
simranarawattigi05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilesh Mishra |
| Designation |
Professor and HOD |
| Affiliation |
Krishna Vishwa Vidyapeeth, Karad |
| Address |
Room no. 24, Dept of Oral and Maxillofacial Surgery, School of Dental Sciences, Krishna Vishwa Vidyapeeth, Karad, Maharashtra
School of Dental Sciences, Krishna Vishwa Vidyapeeth, Karad, Maharashtra
Satara
MAHARASHTRA
415539
India |
| Phone |
9158542384 |
| Fax |
9158542384 |
| Email |
nileshmishra1934@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilesh Mishra |
| Designation |
Professor and HOD |
| Affiliation |
Krishna Vishwa Vidyapeeth, Karad |
| Address |
School of Dental Sciences, Krishna Vishwa Vidyapeeth, Karad, Karad, Maharashtra
Room no. 24, Second floor, Dept of Oral and Maxillofacial Surgery, School of Dental Sciences, Krishna Vishwa Vidyapeeth, Karad, Maharashtra
Satara
MAHARASHTRA
415539
India |
| Phone |
9158542384 |
| Fax |
9158542384 |
| Email |
nileshmishra1934@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krishna Vishwa Vidyapeeth (Deemed to be University), Karad, Maharashtra, India
Pincode: 415539 |
|
|
Primary Sponsor
|
| Name |
Simran Arawattigi |
| Address |
Krishna Vishwa Vidyapeeth, "Deemed to be university" Karad, Malkapur, Karad (District: Satara), Maharashtra, India.
Pincode: 415539 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Nilesh Mishra |
Dept. no. 24, Department of Oral and Maxillofacial Surgery, School of Dental Sciences, Krishna Vishwa Vidyapeeth, Karad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Simran Arawattigi |
Krishna Vishwa Vidyapeeth (Deemed to be University) Karad |
Dept. no. 24, Department of Oral and Maxillofacial Surgery, School of Dental Sciences, Krishna Vishwa Vidyapeeth, Karad
Satara
MAHARASHTRA |
7083305744
simranarawattigi05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KVV |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M858||Other specified disorders of bonedensity and structure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mersilk 3/0 Suture, ETHICON, India |
Braided Silk Suture
Braided - For easy handling and secure knot tying.
Coated - With wax to give “hand†to the suture.
Does not become limp or brittle.
Natural - Produced from cocoons of the silk worm
Bombyx Mori.
Non-Absorbable - Provides prolonged tensile strength retention
in tissue for up to 3 months.
Colour - Black or ivory.
Range - Braided 7-0 to 4 (U.S.P.) Supplied as needled sutures and ligatures.
Sterilisation - By Irradiation.
Total duration: 6-8 minutes |
| Intervention |
N-BUTYL-2-CYANOACRYLATE GLUE
(Truseal, Healthium, Medtech, India)
|
Truseal wound Closure device Topical Skin Adhesive N-BUTYL-2-CYANOACRYLATE 10 units 0.25ml Healthium
Total duration: 1 minute to 2.5 minutes |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of both genders aged between 30-70 years.
2. Patients indicated for alveoloplasty.
3. Patients non-allergic to cyanoacrylates and silk.
4. Patients willing for participation in the study and give written informed consent.
5. Patients indicated for alveoloplasty in both sides of either maxilla or mandible.
|
|
| ExclusionCriteria |
| Details |
1. Patients who are allergic to cyanoacrylates and silk.
2. Patients out of the age range of 30-70 years.
3. Patients with compromised systemic health - uncontrolled diabetes, severe cardiovascular diseases or immunocompromised patients
4. Patients on steroid therapy etc.
5. Inadequate bone volume, active infections, poor oral hygiene, haemorrhagic disorders, severe anxiety, psychological disorders.
6. Chronic smoking habit, pregnancy and recent radiation therapy.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intra-operative ease of closure of the surgical site and efficient hemostasis with use of cyanoacrylate glue.
|
Follow up:
Clinical assessment will be performed at immediate post-operatively, 3rd, 7th, 14th and 21st days post-operatively.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effective wound healing, lesser pain & no suture tracks evident on operative site, post-operatively,
can be used as relevantly as conventional method of wound closure, that is, suturing |
Follow up: Clinical assessment will be performed at immediate post-operative 3rd, 7th, 14th & 21st days post-operatively. |
|
|
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 2 |
|
Date of First Enrollment (India)
|
23/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Will be provided on request to the email ID of principal investigator
- For how long will this data be available start date provided 16-12-2024 and end date provided 16-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a split-mouth comparative, clinical and prospective study of patients undergoing alveoloplasty reporting to the Department of Oral and Maxillofacial Surgery, SDS, KVV. Patients with bony spicules/protuberances indicated for alveoloplasty will be enrolled for the study. All patients requiring alveoloplasty, fulfilling inclusion criteria and giving consent for the study will be included in study, after the approval of ethical committee. The participants will be analysed on the basis of bony spicules present on both sides of either maxilla or mandible. For this study, a split-mouth, comparative analysis will be done by the division of two operative sites; i.e. Site A (Control site) and Site B (Study site). SITE A (Control site) will get treated with (closure with 3-0 silk suture) and SITE B (Study site) will get treated with (closure with N-butyl 2 cyanoacrylate glue) The right side of the arch will be taken as control site while the left will be study site. Post-operatively, clinical assessment will be performed at immediate 3rd, 7th, 14th and 21st day post-operatively. Parameters to be evaluated will include: Intra-orally: The time of intra-oral wound closure (in mins) will be divided by the length of incision margin taken (in mm) to evaluate the mean time taken to achieve intra-oral incision closure depending the length of incision.
Post-operatively: The evaluation of pain assessment (by VAS Scale) and wound healing index score by Landry, Turnbull and Howley. Clinical evaluation of the surgical sites will be done by blinded observer on 14th and 21st post-operative days. All post-operative parameters will be recorded on 3rd, 7th, 14th and 21st follow-up days respectively.
|