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CTRI Number  CTRI/2026/02/104196 [Registered on: 18/02/2026] Trial Registered Prospectively
Last Modified On: 17/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study on dental implant patients to evaluate whether a herbal gel reduces harmful bacteria and helps maintain supporting bone around implants 
Scientific Title of Study   A Clinico Microbiological Evaluation of the Effect of Herbal Extract on Peri Implant Microbial Profile and Marginal Bone Levels A Randomized Clinical Trial 
Trial Acronym  Periherbimp 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Reshma Karkera  
Designation  Professor 
Affiliation  Rajiv Gandhi Institute of Health Sciences, Bangalore 560041 
Address  A.J. Institute of Dental Sciences NH 66 Kuntikana Mangalore

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9986882404  
Fax    
Email  drrkka19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Reshma Karkera  
Designation  Professor 
Affiliation  Rajiv Gandhi Institute of Health Sciences, Bangalore 560041 
Address  A J Institute of dental sciences, Kuntikana, NH 66,near fire station, Mangalore

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9986882404  
Fax    
Email  drrkka19@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Reshma Karkera  
Designation  Professor 
Affiliation  Rajiv Gandhi Institute of Health Sciences, Bangalore 560041 
Address  A J Institute of Dental Sciences NH66, Kuntikana, near fire station, Mangalore

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9986882404  
Fax    
Email  drrkka19@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Gowri S Gaddadh 
Address  A.J Institute of Dental Science, NH 66, Kuntikana, near fire station, Mangalore, DK, Karnataka, India  
Type of Sponsor  Other [Dr Reshma Karkera] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Reshma Karkera  Department of Prosthodontics and crown and bridge Room NO. 4 ,A.J. Institute of Dental Sciences  AJIDS NH66 Kuntikana Mangalore 575004
Dakshina Kannada
KARNATAKA 		 9986882404

drrkka19@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Herbal Extract Gel  Cissus quadrangularis stems and Curcuma longa rhizomes will be washed, dried, powdered, and mixed. Five grams of the combined powder will be boiled in 100 mL distilled water for 30 minutes to obtain an aqueous decoction, filtered, and treated with ethanol to precipitate the extract. The dried extract will be powdered and stored in a desiccator. A 3% CMC-Na gel base will be prepared, and a 5% herbal extract gel will be formulated by mixing 0.5 mL of extract with 9.5 mL of the gel base to obtain 10 mL of final preparation 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Patient aged above 18 years and below 65 years.
2) Periodontally and systemically healthy.
3) Patients scheduled for dental implants.
4) Partially edentulous patient with both teeth adjacent to the implant area.
5) A healed edentulous area with adequate hard and soft tissue.
6) No history of implant failure in that area.
7) Patient is willing to participate in the study.
 
 
ExclusionCriteria 
Details  1)Patients with any evidence of systemic diseases such as diabetes mellitus, peripheral vascular disease, blood clotting disorders, or collagen vascular disease.
2) Any person who after blood investigations, are found to be HBsAg positive or HIV positive.
3) Any contraindications for implant placement.
4) Need for simultaneous soft and hard tissue augmentation.
5) History of allergy to any medications/ materials
6) Uncooperative patient/ patient diagnosed with intellectual disability
7) Presence/ History of periodontal disease
8) Pregnancy and lactation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Microbial analysis of Porphyromonas gingivalis, Fusobacterium nucleatum, Staphylococcus aureus, and Streptococcus sanguinis will be performed on paper points collected to assess bacterial load and compare microbial colonisation between adjunctive herbal extract applications and conventional peri-implant therapy  Sample will be collected immediately before surgery (baseline) and on the 7th postoperative day to assess bacterial load 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the amount of crestal bone resorption, crestal bone levels around the implants were assessed using cone-beam computed tomography in both adjunctive herbal extract applications and conventional peri-implant therapy.  CBCT analysis will be done immediately after surgery baseline and at three months postoperatively  
 
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   Phase 2 
Date of First Enrollment (India)   01/05/2026 
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="2"
Months="0"
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 is designed to evaluate the adjunctive effect of a five percent herbal extract gel containing Cissus quadrangularis and Curcuma longa when applied to the implant cover screw during dental implant placement in the test group while control group receives conventional peri implant therapy. Investigations include collection of peri implant sulcus samples at baseline and on the seventh post operative day of microbial analysis and assessment of crestal bone levels using CBCT immediately after surgery and at three months. Through comparative analysis between the test and control groups the study seeks to determine whether the herbal get provides antimicrobial benefits and promotes improved crestal bone preservation during early healing. The findings may contribute to evidence based to advancements in peri implant therapy and support the potential role of herbal adjuncts in enhancing implant success and peri implant tissue health. 
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