| CTRI Number |
CTRI/2026/03/106965 [Registered on: 27/03/2026] Trial Registered Prospectively |
| Last Modified On: |
26/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to evaluate the effect of one percent Resveratrol gel and one percent Chitosan gel on bone healing and stability of dental implants |
|
Scientific Title of Study
|
Effect of one percent Resveratrol gel and one percent Chitosan gel application on osseointegration and crestal bone changes around dental implants |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aitha Lakshmi Pranathi |
| Designation |
Post Graduate |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Periodontology, Room no-8, Sibar Institute of Dental sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8688228638 |
| Fax |
|
| Email |
pranathiaitha23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Boyapati Ramanarayana |
| Designation |
Professor |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Periodontology, Room no-8, Sibar Institute of Dental sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9490144365 |
| Fax |
|
| Email |
dr.ramanarayana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aitha Lakshmi Pranathi |
| Designation |
Post Graduate |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Periodontology, Room no-8, Sibar Institute of Dental sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8688228638 |
| Fax |
|
| Email |
pranathiaitha23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, Room no-8, Sibar Institute of Dental sciences, Takkellapadu, Guntur,Andhra Pradesh ,India,Pincode- 522509 |
|
|
Primary Sponsor
|
| Name |
Aitha Lakshmi Pranathi |
| Address |
Department of Periodontology, Room no-8, Sibar Institute of Dental sciences, Takkellapadu, Guntur, Andhra Pradesh, India, Pincode-522509 |
| 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 Aitha Lakshmi Pranathi |
Sibar Institute of Dental Sciences |
Department of Periodontology, Room no-8, Sibar Institute of Dental sciences, Takkellapadu, Guntur, Andhra Pradesh, India, Pincode-522509
Guntur
ANDHRA PRADESH |
8688228638
pranathiaitha23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe- SIBAR INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: X||New Technology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional implant placement |
Implants will be placed following conventional surgical protocol without the application of any adjunctive gel material. This group will serve as the control for comparison of implant stability (RFA values) and crestal bone level changes (grid IOPA analysis).
|
| Intervention |
One percent chitosan gel |
Gel will be applied locally on the implant prior to implant insertion into the osteotomy site immediately to evaluate its effect on osseointegration and crestal bone changes. |
| Intervention |
One Percent Resveratrol gel |
Gel will be applied locally on the implant prior to implant insertion into the osteotomy site immediately to evaluate its effect on osseointegration and crestal bone changes. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with partial edentulism indicated for implant-supported tooth replacement.
2.Individuals with an age group of 35-50 years of either gender.
3.Presence of adequate keratinized mucosa (minimum 1 mm) in the edentulous site.
4.Apparently healthy individuals.
5.Individuals with bone density classified as D2 and D3 type of bone.
|
|
| ExclusionCriteria |
| Details |
1.Individuals with parafunctional habits.
2.Any forms of tobacco users.
3.Pregnant and lactating women.
4.Subjects taking any medication which effect healing and bone metabolism.
5.Subjects with a history of immune disease, uncontrolled diabetes, ongoing chemotherapy radiation treatment to head and neck, alcohol or drug abuse, or psychological instability.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical outcome - Implant stability
Radiological outcome – bone density and bone width, Crestal bone level changes |
Time points(clinical outcome) –Immediate post op ,3 months
Time points(Radiological outcomes)- Immediate post op,
3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2026 |
| 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)
|
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
|
| Successful dental implantation depends on optimal osseointegration and maintenance of crestal bone levels. Resveratrol (a polyphenolic compound with anti-inflammatory and osteogenic properties) and chitosan (a biocompatible polymer with osteoconductive and antimicrobial effects) may enhance peri-implant healing; however, clinical evidence regarding their local application is limited. This randomized controlled clinical study will evaluate the effect of one percent resveratrol gel and one percent chitosan gel on osseointegration and crestal bone changes around dental implants. Thirty implants will be allocated into three groups (ten each): Group one (control group), Group two (one percent resveratrol gel), and Group three (one percent chitosan gel).Implant stability (ISQ) will be assessed using Resonance Frequency Analysis (RFA), and crestal bone levels will be evaluated using standardized grid intraoral periapical radiographs (IOPA). This study determine whether local application of these gels improves implant stability and reduces crestal bone loss compared to control. | |