| CTRI Number |
CTRI/2021/09/036669 [Registered on: 21/09/2021] Trial Registered Prospectively |
| Last Modified On: |
20/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To assess and compare the bone loss around mini-implant retained overdenture placed by full thickness flap versus flapless surgery in the mandibular arch among controlled Type 2 Diabetic patients utilizing 3-dimensional Cone Beam Computed Tomography (CBCT). |
|
Scientific Title of Study
|
The comparison of flap and flapless technique of placing mini implants supporting mandibular over denture on crestal bone loss in diabetic individuals- A randomised control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akshatha D D |
| Designation |
PG Student |
| Affiliation |
Faculty of dental sciences of MSRUAS |
| Address |
Department of prosthodontics
FDS of M S Ramaiah university of applied sciences
MSRIT Post, MSR College Rd, M S R Nagar, Mathikere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560054
India |
| Phone |
9480288474 |
| Fax |
|
| Email |
akshatha.dd94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Babashankara Alva M |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of dental sciences of MSRUAS |
| Address |
Department of prosthodontics
FDS of M S Ramaiah university of applied sciences
MSRIT Post, MSR College Rd, M S R Nagar, Mathikere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560054
India |
| Phone |
9663115186 |
| Fax |
|
| Email |
babashankaralva@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Babashankara Alva M |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of dental sciences of MSRUAS |
| Address |
Department of prosthodontics
FDS of M S Ramaiah university of applied sciences
MSRIT Post, MSR College Rd, M S R Nagar, Mathikere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560054
India |
| Phone |
9663115186 |
| Fax |
|
| Email |
babashankaralva@gmail.com |
|
|
Source of Monetary or Material Support
|
| Individual- Dr Akshatha D D |
|
|
Primary Sponsor
|
| Name |
Akshatha D D |
| Address |
Department of prosthodontics
FDS of M S Ramaiah university of applied sciences
MSRIT Post, MSR College Rd, M S R Nagar, Mathikere, Bengaluru, Karnataka |
| Type of Sponsor |
Other [Individual] |
|
|
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 Akshatha D D |
Faculty of dental sciences of M S Ramaiah university of applied sciences |
Department of Prosthodontics,
Room no. 4
Faculty of dental sciences of MSRUAS, MSR nagar, Matthikere- Banglore 560054
Bangalore
KARNATAKA |
9480288474
akshatha.dd94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics committee for Human Trials of M S Ramaiah University of Applied Sciences |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, (2) ICD-10 Condition: Z40-Z53||Encounters for other specific health care, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Flapless technique |
Dental implant placement by open flap technique followed by loading with denture after 3 months |
| Comparator Agent |
Open flap technique |
Open flap technique of dental implant placement and loading after 3months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with completely edentulous maxillary and mandibular arches.
Glycosylated haemoglobin (HbA1c) levels 6.1–8 %.
Extraction site healed for at least 12 weeks.
Adequate bone width and height to place an implant of at least 2.4 mm diameter and 10 mm length.
|
|
| ExclusionCriteria |
| Details |
Subjects requiring bone augmentation procedure. before or during implant placement.
Microvascular complications such as nephropathy, neuropathy and retinopathy.
Habit of smoking, pan chewing and chronic alcoholism.
Pre-cancerous lesions and conditions.
medical contra indication for implant surgery.
Severe bony defects in the implantation site.
Poor neuromuscular control.
Severe prognathism or retrognathism of jaws. |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| flapless surgical technique is effective in reducing the crestal bone loss around mini implant supported overdenture among completely edentulous controlled Type 2 diabetic patients. |
9months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Flapless surgical technique is effective in reducing bone loss around dental implants. |
9 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
22/09/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Completely edentulous patients using removable complete denture often suffer from lack of retention and stability of dentures. Solution for this is rehabilitation with dental implants. 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. Traditional surgical implant placement protocol uses a full thickness mucoperiosteal flap, which might lead to initiation of crestal bone loss and may be a contributory factor for implant failure among diabetic patients. Studies have shown that a flapless approach for implant placement has a positive effect on crestal bone remodelling as well as added effects of better soft and hard tissue healing and patient comfort. Also, the dimension of mini implant further simplifies the process. So, this study aims to To assess and compare the bone loss around mini-implant retained overdenture placed by full thickness flap versus flapless surgery in the mandibular arch among controlled Type 2 Diabetic patients utilizing 3-dimensional Cone Beam Computed Tomography. |