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CTRI Number  CTRI/2025/12/098451 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 31/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison of Boric Acid Gel Adjunctive Therapy Versus Standard Implant Protocol on Implant Stability, Osteocalcin levels and Crestal bone level 
Scientific Title of Study   EVALUATION OF EFFECT OF 0.75% BORIC ACID GEL ON IMPLANT STABILITY, CRESTAL BONE LEVEL AND OSTEOCALCIN LEVELS AROUND DENTAL IMPLANTS. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pallavi Sitaram Kamble 
Designation  Associate Professor 
Affiliation  Bharati Vidyapeeth Dental College and Hospital 
Address  Bharati Vidyapeeth Dental College and Hospital Bharati Medical Campus walneswadi sangli

Sangli
MAHARASHTRA
416414
India 
Phone  7756811987  
Fax    
Email  kamble.pallavi60@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Thamrai Selvan 
Designation  Professor 
Affiliation  Saveetha Dental College and Hospital Chennai 
Address  Poonamallee High Rd, Velappanchavadi, Chennai Tamil Nadu

Chennai
TAMIL NADU
600077
India 
Phone  9884276922  
Fax    
Email  thamaraiselvan@saveetha.com  
 
Details of Contact Person
Public Query  
Name  Dr Pallavi S Kamble 
Designation  Professor 
Affiliation  Bharati Vidyapeeth (Deemed to be) University Dental College and Hospital 
Address  Bharati Vidyapeeth Medical Campus, Bharati Dental College and Hospital Walneswadi Sangli

Sangli
MAHARASHTRA
416414
India 
Phone  7756811987  
Fax    
Email  kamble.pallavi60@gmail.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth Dental College and Hospital Sangli Bharati Medical Campus walneswadi sangli 
 
Primary Sponsor  
Name  Bharati Vidyapeeth Dental College and Hospital 
Address  Bharati Medical Campus Walneswadi Sangli 416416 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
A G M College of Pharmacy   Sri Navagrahateertha Kshetra Varur 581207 Hubli 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pallavi Sitaram Kamble  Department of Periodontology  Bharati Vidyapeeth (Deemed to be) University Dental College and Hospital Walneswadi Sangli
Sangli
MAHARASHTRA 		 7756811987

kamble.pallavi60@gmail.com 
Dr Thamrai Selvan  Department of Periodontology  Saveetha Dental College and Hospital Chennai
Chennai
TAMIL NADU 		 9884276922

thamaraiselvan@saveetha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee BVDU Medical College and Hospital Sangli  Approved 
Saveetha Dental Colege - Institutional Kaman Ethical Commitee (SDC-HEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  partially edentulous individuals who require dental implant placement as dental rehabilitation 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.75% Boric Acid Gel  Boric Acid Gel will be prepared with the help of Dr. S. A. Sreenivas. Principal at AGM College of Pharmacy Varur, Hubballi, Dharwad District Karnataka As per his instructions BA gel will be prepared by adding the required amount of different gelling agents in water for a specific time period. Gelling agents used will be carbopol (lubrizol advanced materials india private®, mumbai, india), sodium carboxymethylcellulose, and methylcellulose (3% w/v). A weighed amount of boric acid and zinc oxide will be dissolved separately in ethanol, and this solution then slowly added to the polymer dispersion. Following this, glycerin (0.5 ml) and preservative propylparaben (0.02 mg) will be added to the dispersion and stirred continuously until a homogeneous product was formed in this way, 0.75% of BA in situ gel will be prepared.   
Comparator Agent  NIL  PLACEBO 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  99.00 Day(s)
Gender  Both 
Details  Patients of age 18 years and above
Signed informed consent given by the patient.
Patients with missing tooth on maxilla/mandible
Have at least one tooth, both single or multi-rooted, indicated to extraction due to crack, fracture, or perforation and the possibility of placement of a dental implant
Adequate bone dimensions for implant placement without the need for guided bone regeneration procedures
Post extraction alveolar sockets with at least three remaining walls
Good general health, which allows for dental implant surgery
 
 
ExclusionCriteria 
Details  Active orthodontic treatment
Previous periodontal surgery
Systemic diseases like DM Type – 1, Hypertension, Hypothyroidism, etc.
Use of anti – coagulant therapy
Use of any drugs that might lead to gingival enlargement
History of radiation therapy in head and neck region
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Implant stability
Crestal Bone levels
Osteocalcin values in PICF 		 3 months
6 months
9 months 
 
Secondary Outcome  
Outcome  TimePoints 
Perimplant soft tissue health
Postoperative healing and inflammatory response
Correlation of clinical and radiographic parameters 		 3 months
6 months
9 months 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   17/12/2025 
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="11"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

This randomized controlled clinical trial aims to evaluate the effect of 0.75% boric acid gel on peri-implant healing by assessing three key outcome parameters: implant stability, crestal bone level, and osteocalcin concentration around dental implants. Boric acid, known for its anti-inflammatory and osteogenic properties, may enhance osseointegration and improve peri-implant tissue health. Eligible partially edentulous patients requiring implant placement will be randomly allocated into a test group (boric acid gel application) and a control group (no gel application).

Standardized implant placement will be performed using an endosseous implant system.   implant stability will be measured using resonance frequency analysis (Osstell ISQ) at baseline, 3, 6, and 9 months.  will be assessed using CBCT at baseline, 3, 6, and 9 months. Peripheral implant crevicular fluid (PICF) will be collected at scheduled visits to quantify osteocalcin using ELISA.

The study aims to determine whether the adjunctive application of boric acid gel improves implant stability, crestal bone loss, and osteocalcin level for bone formation.  Findings may support the use of boric-acid–based biomaterials as cost-effective adjuncts for improving implant success and long-term peri-implant health.

 
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