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CTRI Number  CTRI/2024/09/073402 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 02/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   "Comparing Two Types of Dental Implants: A clinical Study" 
Scientific Title of Study   A Comparison of Conventional and Mini Single Implant retained Mandibular Overdenture in controlled diabetic individuals 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shivangini Gumme 
Designation  Post-graduate student  
Affiliation  Faculty of Dental Sciences, MS Ramaiah University of Applied Sciences 
Address  Department of Prosthodontics, Roon no 4, 1st floor, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, NEW BEL Road
second floor,Vijaylakshmi nilaya, jaladarshini layout, sanjay nagar, bangalore 560094
Bangalore
KARNATAKA
560054
India 
Phone  8618153862  
Fax    
Email  gummeshivangini@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Babashankara Alva M 
Designation  Assisstant Professor 
Affiliation  Faculty of Dental Sciences, M S Ramaiah University of Applied Sciences 
Address  Department of Prosthodontics, roon no 4, 1st floor, Faculty of Dental Sciences, M S Ramaiah University of Applied Sciences

Bangalore
KARNATAKA
560054
India 
Phone  9663115186  
Fax    
Email  babashankaralva@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shivangini Gumme 
Designation  Post-graduate student  
Affiliation  Faculty of Dental Sciences, M S Ramaiah University of Applied Sciences 
Address  Department of Prosthodontics, Roon no 4, 1st floor, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, NEW BEL Road
ssecond floorVijaylakshmi nilaya, jaladarshini layout, sanjay nagar, bangalore 560094
Bangalore
KARNATAKA
560054
India 
Phone  8618153862  
Fax    
Email  gummeshivangini@gmail.com  
 
Source of Monetary or Material Support  
Department of Prosthodontics, room no 4, 1st floor, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, New Bel Road, Bangalore, Karnataka, 560054 
 
Primary Sponsor  
Name  Dr Shivangini Gumme 
Address  Faculty of Dental Sciences, M S Ramaiah University of Applied Sciences, New Bel Road, Bangalore, Karnataka, 560054 
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 
Dr Shivagini Gumme  Ramaiah Dental Hospital   Department of Prosthodontics, Roon no 4, 1st floor, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, NEW BEL Road
Bangalore
KARNATAKA 
8618153862

gummeshivangini@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
University Ethics Committee for HumanTrials Approval Certificate, M S Ramaiah University of Applied Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K082||Atrophy of edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2-piece conventional implant retained mandibular overdenture  patients with completely edentulous arches will be subjected to 2-piece single conventional implant and will be assessed for parameters at baseline and at 3 months 
Intervention  2-piece single mini implant retained overdenture   patients with completely edentulous arched will be subjected to 2-piece mini implant and assessed for parameters at placement and at 3 months 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects with completely edentulous maxillary and mandibular arches
2. Patients aged between 50-70 yrs
3. Both male and female patients
4. Patients with Glycosylated haemoglobin (HbA1c) levels at 6–6.5 %
5. Extraction site healed for at least 12 weeks
6. Adequate bone width and height to place an implant of at least 2.4 mm diameter and 10 mm length
 
 
ExclusionCriteria 
Details  1. Subjects requiring bone augmentation procedure before or during implant placement
2. Any Microvascular complications such as nephropathy, neuropathy and retinopathy
3. Habit of smoking, pan chewing and chronic alcoholism
4. Pre-cancerous lesions and conditions
5. Subjects with medical contra-indications for implant surgery
6. Severe bony defects in the implantation site
7. Poor neuromuscular control
8. Severe prognathism or retrognathism of jaw
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To assess the crestal bone loss around the 2-piece single conventional and mini implant retained mandibular overdenture.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
2. To assess the patient satisfaction for 2-piece single conventional and mini single implant retained overdenture.  3 months 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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)   15/09/2024 
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="3"
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 - 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 who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 01-12-2024 and end date provided 01-12-2029?
    Response - Immediately following publication. No end date.

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

Implant retained overdentures have now become the choice of treatment for removable complete overdenture. Implants such as mini-implants and conventional implants have been used to stabilize the mandibular overdenture. (Weerapan et al 2016). Diabetes Mellitus is a metabolic disorder and considered a relative risk for dental implant therapy. As there is delayed wound and bone healing and compromised immunity among diabetic patients, many of them are denied the benefits of dental implant therapy (Yadav et al. 2018). 2-piece Mini-implants are often being recommended because of their reduced diameter (<3.0 mm) which enables insertion in narrow ridges. Mini-implants are also interesting from an economic perspective, due to their reduced cost compared with standard fixtures and lower operative time needed (Griffitts et al. 2005).Systematic reviews evaluating the clinical viability of single implants retaining overdentures concluded that their survival and patient satisfaction increased even with a single implant retaining the overdenture (Batista et al 2019). Based on the data available, crestal bone loss is affected by implant design, formation of biologic width, implant design, implant surface, insertion depth, platform switching, postsurgical manipulation and micro gap and stability between the implant and abutment (Maier, F.M. 2016). There have been various studies on the number of dental implants used to stabilize the denture but there has been limited studies regarding the comparison between a 2-piece single conventional and mini implant for a mandibular overdenture used in diabetic individuals. Such a treatment is more cost-effective and affordable for patients. Hence, there’s a need for this study.

Aim of the study: The aim of the study is to evaluate the crestal bone loss and the patient satisfaction between Conventional and Mini single implant supported mandibular overdenture

Objectives of the study:1. To assess the crestal bone loss around the conventional and mini single implant supported mandibular overdenture. 2. To assess the patient satisfaction for conventional and mini single implant supported overdenture.

Methodology: 22 participants satisfying the predetermined inclusion and exclusion criteria will be selected for this study. The participants will be randomly assigned into two groups (Group A – Conventional implant and Group B – Mini implant). Each group will have 11 participants; a single implant will be placed in symphysis of the mandible. Conventional loading protocol will be followed after 3 months. Crestal bone loss will be assessed with CBCT at mesial, distal, buccal, lingual sites immediately after implant placement, 3rd month (loading), and 9th month from implant placement. Patient satisfaction will be evaluated with a questionnaire at the end of 9th month.

 
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