FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/077001 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 23/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Nine months comparison peri-implant scores of dental implants placed with low-speed drilling without irrigation and conventional drilling with irrigation  
Scientific Title of Study   Clinico-radiographic comparison of dental implants placed with low-speed drilling without irrigation and conventional drilling with irrigation – A randomized controlled study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1315-2816  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aaron F Gomes 
Designation  Professor and Head, Department of Periodontology and Oral Implantology 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  Department of Periodontology & Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140

Dehradun
UTTARANCHAL
248140
India 
Phone  9860597402  
Fax    
Email  aarongomes@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aaron F Gomes 
Designation  Professor and Head, Department of Periodontology and Oral Implantology 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  Department of Periodontology & Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140


UTTARANCHAL
248140
India 
Phone  9860597402  
Fax    
Email  aarongomes@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aaron F Gomes 
Designation  Professor and Head, Department of Periodontology and Oral Implantology 
Affiliation  Uttaranchal Dental and Medical Research Institute 
Address  Department of Periodontology & Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140


UTTARANCHAL
248140
India 
Phone  9860597402  
Fax    
Email  aarongomes@hotmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Aaron F Gomes 
Address  Dept of Periodontology and Oral Implantology, Uttaranchal Dental and Medical Research Institute, Majri Grant, Dehradun 248140 
Type of Sponsor  Other [Self] 
 
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 
Aaron F Gomes  Uttaranchal Dental and Medical Research Institute   Room No 10, Dental Implant Centre, Dept of Periodontology and Oral Implantology, Uttaranchal Dental and Medical Research Institute, Majri Grant, Haridwar road
Dehradun
UTTARANCHAL 
9860597402

aarongomes@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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, (2) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  A cohort of partially edentulous patients will be treated with placement of dental implants with a drilling speed of 800-400 rpm with copious saline irrigation. These particpants will be evaluated for periimplant crestal bone levels and periimplant plaque and mucosal scores at 3, 6, and 9 months after implant fixture surgery  
Intervention  Test Group  A cohort of partially edentulous patients will be treated with placement of dental implants with an intermittent drilling at a speed of 200-100 rpm with no saline irrigation. These particpants will be evaluated for periimplant crestal bone levels and periimplant plaque and mucosal scores at 3, 6, and 9 months after implant fixture surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Healthy Indian patient
Partially edentulous
Sufficient bone height/width for implant placement
Ready to come for 6-month recall 
 
ExclusionCriteria 
Details  Active Periodontal Infection.
Unresolved extraction wounds or inadequate bone at the time of implant placement
Lack of motivation and/or compliance
Moderate/heavy smoking
Bruxism
Any medical condition that contraindicates surgery
Pregnancy 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Peri implant crestal bone level at mesial and distal aspect of the implant  R0- radiograph taken soon after placement of implant.
R3- Radiograph taken 3 months after placement of implant and before placing the final prosthesis.
R6- Radiograph taken 6 months after placement of implant, 3 months after placement of final prosthesis.
R9- radiograph taken after 9 months of implant placement surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Peri implant mucosal index
modified Plaque index
modified Sulcus Bleeding Index
Implant mobility scale
Peri-implant Sulcus Probing Depth
 
6 and 9 months after implant placement surgery 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   22/11/2024 
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="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aarongomes@hotmail.com].

  6. For how long will this data be available start date provided 01-11-2025 and end date provided 30-11-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Background: The present study aims to investigate the changes in crestal bone levels and the changes in implant scores after placing implants using two different drilling-protocols, i.e., low-speed-drilling without irrigation and conventional-drilling with saline irrigation, over a follow-up of 9 months.

Nh   Null hypothesis: there is no difference in the mesial distal crestal bone levels, peri implant mucosal index value, modified plaque index score, modified sulcus bleeding index scores, implant mobility scale, peri implant sulcus probing depth between implants placed after drilling with 800-400 rpm with copious saline irrigation and implants placed after intermittently drilling with 200-100 rpm without irrigation.    

Material and Methods: Twenty participants will be enrolled from a dental teaching institute. Participants who fulfill the inclusion criteria will be randomly divided equally in two study groups: 1) test group: low-speed-drilling at 200-100 rpm without irrigation and 2) control group: conventional-drilling at 800-400rpm with saline irrigation. The changes in proximal radiographic crestal bone levels will be measured at baseline (immediately after placement of implant), and after 3-, 6-, 9- months. Changes in crestal bone levels will be compared at time-intervals of 3-, 6- and 9- months. These changes will also be calculated as a percentage of implant length. Clinical and radiographic scores of modified Plaque Index, Peri-implant Mucosal Index, modified Sulcus Bleeding Index, Misch’s Clinical Implant Mobility Scale, Peri-implant sulcus probing depth, Peri-implant clinical attachment level, Presence of peri-implant suppuration, Presence of peri-implant radiolucencies will be evaluated after 6-, 9 months in both groups. Second stage surgery will be performed after 3-4 months and cement retained implant crowns will be  delivered. Data analysis will be performed using paired t-test between both groups and a p-value  of ≤0.05 was considered statistically significant.

 
Close