| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gummeshivangini@gmail.com].
- 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.
- 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. |