| CTRI Number |
CTRI/2025/06/088452 [Registered on: 09/06/2025] Trial Registered Prospectively |
| Last Modified On: |
05/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on wound healing and bacteria in the mouth using herbal-coated sutures |
|
Scientific Title of Study
|
Intraoral clinical evaluation of wound healing and microbial dynamics of an herbal gel coated suture - a randomised control trial |
| Trial Acronym |
okra |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manasa Bhide |
| Designation |
MDS postgraduate student |
| Affiliation |
A.J Institute of Dental Sciences |
| Address |
A.J Institute of Dental Sciences
Kuntikana NH-66, Mangalore
Kuntikana NH-66, Mangalore
575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
6361297125 |
| Fax |
|
| Email |
manasabhide2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reshma Karkera |
| Designation |
Professor |
| Affiliation |
A.J Institute of Dental Sciences |
| Address |
A.J Institute of Dental Sciences
Kuntikana NH-66, Mangalore
Kuntikana NH-66, Mangalore
575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9986882404 |
| Fax |
|
| Email |
drrkka19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manasa Bhide |
| Designation |
MDS postgraduate student |
| Affiliation |
A.J Institute of Dental Sciences |
| Address |
A.J Institute of Dental Sciences
Kuntikana NH-66, Mangalore
Kuntikana NH-66, Mangalore
575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
6361297125 |
| Fax |
|
| Email |
manasabhide2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| A.J Institute of Dental Sciences,
Kuntikana NH-66, Mangalore
Karnataka, India
575004 |
|
|
Primary Sponsor
|
| Name |
Dr Manasa Bhide |
| Address |
A.J Institute of Dental Sciences
Kuntikana NH-66, Mangalore, Karnataka,India,575004 |
| 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 Manasa Bhide |
A.J Institute of Dental Sciences |
Department of Prosthodontics ,1st floor,Room number 4,
Kuntikana NH-66, Mangalore,Karnataka,India,575004
Dakshina Kannada
KARNATAKA |
6361297125
manasabhide2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AJIDS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Abelmoschus Esculentus gel coated suture |
Post implant placement or dental surgical procedures,for study group flap approximation will be done by using Abelmoschus Esculentus gel coated suture |
| Comparator Agent |
Conventional black braided silk suture |
Post implant placement or dental surgical procedures, conventional black braided silk suture will be used for flap approximation in control group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for dental implants or dental surgical procedures with the incision site flap wide enough to hold the suture
Periodontally sound patients
Patients with good oral hygiene
Patients willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patients with any evidence of systemic diseases such as diabetes mellitus, peripheral vascular disease, blood clotting disorders, or collagen vascular disease, history of keloid formation or a tendency to form hypertrophic scars.
Any local pathology of soft tissue or bone of acute nature
Any person who after blood investigations, are found to be HBsAg positive or HIV positive
History of allergy to any medication or material
Uncooperative patients; mentally retarded patients
Poorly compliant patients, who are likely not to maintain their oral hygiene or cleanliness of the surgical site
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound healing will be assessed using the Early Wound Healing Index (EHS) on the 3rd and 7th postoperative days. Higher scores will indicate better healing outcomes. |
3rd and 7th postoperative days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Microbial analysis of Staphylococcus aureus and Porphyromonas gingivalis will be conducted on the sutures removed on the 7th postoperative day to evaluate the bacterial load and compare microbial colonization between conventional and Abelmoschus esculentus gel-coated sutures. |
7th day |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
04/08/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This study aims to evaluate wound healing following intraoral implant or minor dental surgical procedures. The patients will be divided into two groups: Group 1 (control) will receive black braided silk sutures, while Group 2 (study group) will receive Abelmoschus esculentus gel-coated sutures for flap approximation. Informed consent will be obtained from all participants, and both groups will receive the same dosage of antibiotics as indicated. Post-operative management and oral hygiene instructions will be provided to all patients. Wound healing will be assessed using the Early Wound Healing Index (EHS) on the 3rd and 7th postoperative days, with clinical parameters such as re-epithelialization, hemostasis, and inflammation scored to determine healing progress. On the 7th day, sutures will be removed under sterile conditions, and a 1 cm segment of the suture will be analyzed for microbial contamination, specifically for Staphylococcus aureus and Porphyromonas gingivalis. |