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CTRI Number  CTRI/2026/02/102909 [Registered on: 03/02/2026] Trial Registered Prospectively
Last Modified On: 02/02/2026
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 Comparing the Stability of Two Types of Dental Implants and Bone Growth Around Them Using Guided Bone Regeneration 
Scientific Title of Study   COMPARATIVE EVALUATION OF IMPLANT STABILITY AND HORIZONTAL BONE AUGMENTATION OF HYDROPHILIC AND CONVENTIONAL IMPLANTS WITH SIMULTANEOUS GUIDED BONE REGENERATION - A CLINICAL AND RADIOGRAPHIC STUDY. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nilakshi Trivedi 
Designation  PG STUDENT 
Affiliation  Government college of Dentistry 
Address  ROOM NO 10 DEPARTMENT OF PERIODONTOLOGY GOVERNMENT COLLEGE OF DENTISTRY INDORE OPPOSITE MY HOSPITAL SARDER PATEL MARG INDORE, Indore MADHYA PRADESH

Indore
MADHYA PRADESH
452001
India 
Phone  07869997381  
Fax    
Email  trivedinilakshi28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SHALEEN KHETARPAL 
Designation  READER 
Affiliation  Government college of Dentistry 
Address  ROOM NO 10 DEPARTMENT OF PERIODONTOLOGY GOVERNMENT COLLEGE OF DENTISTRY INDORE M.P FLAT NO 302,PRIMIUM TOWER 6,SHALIMAR TOWNSHIP A B ROAD, INDORE, INDORE, MADHYA PRADESH

Indore
MADHYA PRADESH
452001
India 
Phone  9827529603  
Fax    
Email  drshaleenk@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SHALEEN KHETARPAL 
Designation  READER 
Affiliation  Government college of Dentistry 
Address  ROOM NO 10 DEPARTMENT OF PERIODONTOLOGY GOVERNMENT COLLEGE OF DENTISTRY INDORE M.P FLAT NO 302,PRIMIUM TOWER 6,SHALIMAR TOWNSHIP A B ROAD, INDORE, INDORE, MADHYA PRADESH

Indore
MADHYA PRADESH
452001
India 
Phone  9827529603  
Fax    
Email  drshaleenk@gmail.com  
 
Source of Monetary or Material Support  
INDIAN SOCIETY OF PERIODONTOLOGY 721 PHASE 3B-1,MOHALI-160059 DENTAL IMPLANTS (BIOLINE 30 units ) DENTAL IMPLANT KIT STRAIGHT ABUTMENT (09 units) HEALING CAP ( 03 units) CLOSED TRAY coping (03 units) Analog (03 units) 
 
Primary Sponsor  
Name  INDIAN SOCIETY OF PERODONTOLOGY  
Address  721,PHASE 3-B1 MOHALI, 160059 
Type of Sponsor  Other [NON PROFITABLE PROFESSIONAL ORGANISATION] 
 
Details of Secondary Sponsor  
Name  Address 
GOVERNMENT AUTONOMOUS COLLEGE OF DENTISTRY INDORE   ROOM NO 10 DEPARTMENT ON PERIODONTOLOGY GOVERNMENT COLLEGE OF DENTISTRY INDORE OPPOSITE TO MY HOSPITAL SARDER PATEL MARG INDORE  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrNilakshi Trivedi  GOVERNMENT COLLEGE OF DENTISTRY INDORE  ROOM NO 10 DEPARTMENT OF PERIODONTOLOGY GOVERNMENT COLLEGE OF DENTISTRY INDORE OPPOSITE MY HOSPITAL SARDER PATEL MARG INDORE, Indore MADHYA PRADESH
Indore
MADHYA PRADESH 		 07869997381

trivedinilakshi28@gmail.com 
 
Details of Ethics Committee  
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  systemic healthy indivisual with missing teeth with horizontal ridge deficiency of upto 3 mm 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  stability and bone augmentation with conventional implant   conventional implants without plasma activation and measurement of clinical parameters using 1.ISQ device at IMMEDIATE, 3 WEEKS , 6 WEEKS, 8 WEEKS AND 3 MONTHS 2.EVALUATE BONE REGENERATION THROUGH CBCT PREOPERATIVE, IMMEDIATE AND POST-OPERATIVE 6 MOTNHS  
Intervention  stability and bone augmentation with hydrophilic implants   hydrophilic implant activation using plasma activation and measurement of clincal parameters using 1.ISQ device AT IMMEDIATE, 3WEEKS, 6 WEEKS, 8 WEEKS AND 3 MONTHS 2.EVALUATE BONE REGENERATION USING CBCT PRE-OPERATIVE, IMMEDIATE, AND POST-OPERATIVE 6 MONTHS 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA
Patients presenting with localized edentulous site with horizontal ridge deficiency upto 3mm in maxilla and mandible.
21-55 years of age of both sex and able to sign an informed consent.
Maintainable oral hygiene 
 
ExclusionCriteria 
Details  1.Patients presenting with alveolar ridge deficiency of more than 3 mm.
2.Presence of active periodontal or dental infections.
3.History of allergy or systemic diseases such as diabetes mellitus, immunocompromising diseases, blood dyscrasias,, cardiovascular disease, renal disease, osteoporosis and with systemic medications like bisphosphonate therapy, anticoagulants, anticonvulsants etc
4.Smokers and/or consuming tobacco in any form.
5.Pregnancy or lactation.
6.Psychiatric illness. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To clinically evaluate and compare stability of hydrophilic and conventional implant using digital implant stability quotient device (ISQ).  a) Baseline
b) 3 weeks
c) 6 weeks
d) 8 weeks
e) 3 months

 
 
Secondary Outcome  
Outcome  TimePoints 
To radiographically evaluate alveolar ridge thickness on CBCT  1) Pre Operative (Rp o)
2) Immediate post operative(Rp1)
3) 6 month post operative (Rp2)

 
 
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/ Phase 3 
Date of First Enrollment (India)   13/02/2026 
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="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   1) The patients will be divided in two equal groups :Group 1 with conventional implants with simultaneous guided bone regeneration and Group 2 with hydrophilic implants with simultaneous guided bone regeneration.

2) To asses the effect of implant surface on stability  ISQ( implant stability quotient ) will be measured at immediate (t0) , 3 weeks(t3), 6 weeks(t6), 8 weeks(t8), 3 months (t12)  and to evaluate bone augmentation around implant surface alveolar ridge thickness will be measured on CBCT at pre-operative( Rp0), immediate (Rp1) and 6 month post -operative (Rp2) at 0mm and 3 mm.
 
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