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CTRI Number  CTRI/2024/12/078669 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On: 24/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Bone loss around the implant placed in thin and thick gingiva 
Scientific Title of Study   Comparative evaluation of crestal bone loss levels around dental implants placed in thick and thin mucosal tissues - a clinicoradiographic 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 Bhutada Chetan Gopal 
Designation  Post graduate student 
Affiliation  Coorg Institute Of Dental Sciences 
Address  Dept. Of Periodontology And Implantology, Room no. 4, K.K. Campus, Magulla village, Virajpet, Kodagu, Karnataka, 571218

Kodagu
KARNATAKA
571218
India 
Phone  9284316954  
Fax    
Email  chetanbhutada6059@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhutada Chetan Gopal 
Designation  Post graduate student 
Affiliation  Coorg Institute Of Dental Sciences 
Address  Dept. Of Periodontology And Implantology, Room no. 4, K.K. Campus, Magulla village, Virajpet, Kodagu, Karnataka, 571218

Kodagu
KARNATAKA
571218
India 
Phone  9284316954  
Fax    
Email  chetanbhutada6059@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Krishnaraj G N  
Designation  Professor 
Affiliation  Coorg Institute Of Dental Sciences 
Address  Dept. Of Periodontology And Implantology, Room no. 4, K.K. Campus, Magulla village, Virajpet, Kodagu, Karnataka, 571218

Kodagu
KARNATAKA
571218
India 
Phone  7259456314  
Fax    
Email  dentalsolutions@gmail.com  
 
Source of Monetary or Material Support  
Coorg Institute Of Dental Sciences, Dept Of Periodontics And Implantology, Room no. 4 K.K. Campus, Magulla village, Virajpet, Kodagu, Karnataka, 571218 
 
Primary Sponsor  
Name  Dr. Bhutada Chetan Gopal 
Address  Coorg Institute Of Dental Sciences, Dept Of Periodontics And Implantology, Room no. 4 K.K. Campus, Magulla village, Virajpet, Kodagu, Karnataka, 571218 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
indian society of periodontology  721, Phase 3B-1, Mohali SAS Nagar. 160060  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bhutada Chetan Gopal  Coorg Institute Of Dental Sciences  Dept Of Periodontics And Implantology, Room no. 4 K.K. Campus, Magulla village, Virajpet, Kodagu, Karnataka, 571218
Kodagu
KARNATAKA 
9284316954

chetanbhutafa6059@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Coorg Institution Of Dental Science  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  dental titanium implant  Measuring the crestal bone loss levels around the subcrestal implants placed in edentulous region covering thick gingival tissue. immediately after implant placement,after 6 months of placement and after 1 year of placement. 
Comparator Agent  dental titanium implant  Measuring the crestal bone loss levels around the subcrestal implants placed in edentulous region covering thin gingival tissue. immediately after implant placement,after 6 months of placement and after 1 year of placement.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Eighteen years of age to sixty five years of age.
2. Fully healed bone sites. (at least 6 months after tooth extraction)
3. No bone augmentation procedures before and during implant placement.
4. Edentulous gap for at least 1 implant in any region of the mouth with minimum 1mm distance range from adjacent tooth/teeth.
5. No medical contraindication for implant surgery.
6. Edentulous site of implant in any region of the mouth with minimum 1mm of mucosal tissue thickness.
 
 
ExclusionCriteria 
Details  1. Poor oral hygiene.
2. Symptoms or history of periodontitis or peri-implantitis treatment.
4. Smoker and alcoholic person.
5. Patients with systemic diseases.
6. Alveolar ridges with bone defects at implantation sites.
7. Attached gingiva ≤ 2 mm.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
More crestal bone loss around the implants placed in thin mucosal tissue.  crestal bone loss will be checked around the implants after 6 months and 12 months of implant placement with CBCT 
 
Secondary Outcome  
Outcome  TimePoints 
Less crestal bone loss around the implants placed in thick mucosal tissue.  crestal bone loss will be checked around the implants after 6 months and 12 months of implant placement with CBCT 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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)   05/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/01/2025 
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  

       i) Rationale: 

              Peri-implantitis can be defined as a crestal bone loss / marginal bone loss (MBL) equal to or greater than three millimeters in the presence of clinical signs such as PPD > 6 mm and BOP. Although MBL does not always lead to peri-implantitis, there is no peri-implantitis without the prior presence of MBL. Berglundh et al. has related this to thickness of soft tissues. They reported that in thin tissues formation of gingival cuff after the second stage surgery resulted in significant bone resorption, in contrast to the thick tissue group, where no statistically reliable bone loss occurred. Hence, it seems that correlation between the thickness of gingival tissue and subsequent bone loss around implants does exist.

      

          ii) Novelty:

                Assesment in mucosal tissue thickness classification given by Egreja et al in 2012. Marginal bone loss will be measured using CBCT in SIDEXIS 4 software with SICATSUITE version 2.0. (Dentsp  ly Sirona; York, US) immediately after implant placement and 6 months later.

 

        iii) Objectives:

          To evaluate and compare the MBL around the implants placed in thin and thick mucosal tissue.   

          iv) Methods:

        The mucosal tissue thickness will be assessed with transgingival probing method given by Dimitrios Kloukos et al in 2021. Radiographic assessments for MBL around the implant will be done immediately after implant placement, 6 months and 12 months later using CBCT. MBL will be measured using SIDEXIS 4 software with SICATSUITE version 2.0. (Dentsply Sirona; York, US)

       

        v) Expected outcome:

               

             Less marginal bone loss in thick mucosal tissue as compared to thin mucosal tissue.

  Hypothesis:

 In thin and thick mucosal tissue there might be marginal bone loss or no marginal bone loss around the implant


 
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