| CTRI Number |
CTRI/2024/10/075362 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Oral Health related Quality of Life and Denture satisfaction score between conventional and single implant mandibular overdenture |
|
Scientific Title of Study
|
Comparative evaluation of Oral Health related Quality of Life and Denture satisfaction score between conventional and single implant supported mandibular overdenture: A Clinical 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 Ananya R M |
| Designation |
Postgraduate student |
| Affiliation |
Sharavathi Dental College and Hospital |
| Address |
The Department of Prosthodontics, Crown and Bridge, and Implantology, Room no: 3, Sharavathi Dental College and Hospital, T H road, Alkola, Shivamogga
The Department of Prosthodontics, Crown and Bridge, and Implantology, Room no: 3, Sharavathi Dental College and Hospital, T H road, Alkola, Shivamogga
Shimoga
KARNATAKA
577205
India |
| Phone |
9986154680 |
| Fax |
|
| Email |
ananyarm0497@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinidhi Bhat |
| Designation |
Professor, Head of the Department |
| Affiliation |
Sharavathi Dental College and Hospital |
| Address |
The Department of Prosthodontics, Crown and Bridge, and Implantology, Room no: 3, Sharavathi Dental College and Hospital, T H road, Alkola, Shivamogga
The Department of Prosthodontics, Crown and Bridge, and Implantology, Room no: 3, Sharavathi Dental College and Hospital, T H road, Alkola, Shivamogga
Shimoga
KARNATAKA
577205
India |
| Phone |
8867768715 |
| Fax |
|
| Email |
drsrinidhibhat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srinidhi Bhat |
| Designation |
Professor, Head of the Department |
| Affiliation |
Sharavathi Dental College and Hospital |
| Address |
The Department of Prosthodontics, Crown and Bridge, and Implantology, Room no: 3, Sharavathi Dental College and Hospital, T H road, Alkola, Shivamogga
The Department of Prosthodontics, Crown and Bridge, and Implantology, Room no: 3, Sharavathi Dental College and Hospital, T H road, Alkola, Shivamogga
Shimoga
KARNATAKA
577205
India |
| Phone |
886776815 |
| Fax |
|
| Email |
drsrinidhibhat@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Department of Prosthodontics, Crown and Bridge, and Implantology, Room no: 3, Sharavathi Dental College and Hospital, T H road, Alkola, Shivamogga |
|
|
Primary Sponsor
|
| Name |
Dr Ananya R M |
| Address |
Room no.3 Department of Prosthodontics, Sharavathi dental college and hospital, T H road, Alkola, Shivamogga, Karnataka -577205 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Srinidhi Bhat |
Room no.3 Department of Prosthodontics, Sharavathi dental college and hospital, T H road, Alkola, Shivamogga, Karnataka -577205 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ananya R M |
Sharavathi dental college and hospital |
Room no.3 Department of Prosthodontics, Sharavathi dental college and hospital, T H road, Alkola, Shivamogga, Karnataka -577205
Shimoga
KARNATAKA |
9986154680
ananyarm0497@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHARAVATHI ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K063||Horizontal alveolar bone loss, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional complete denture |
Questionnaire given to conventional complete denture wearer and single mandibular implant overdenture wearer to assess the comfort between the two at baseline, 1 months and 3 months of denture insertion |
| Comparator Agent |
Denture satisfaction |
Denture satisfaction questionnaire given to conventional complete denture wearers and single implant mandibular overdenture to assess the satisfaction between both the dentures at baseline, 1 months and 3 months |
| Comparator Agent |
OHIP 14
|
OHIP 14 questionnaire given to conventional complete denture wearers and single implant mandibular overdenture to assess the quality of life related to oral health between both the denture wearers at baseline, 1 months and 3 months |
| Intervention |
Single mandibular implant overdenture |
Single implant placed at the symphysis region of the mandible, after 3 months loading of the implant with overdenture prosthesis |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Completely edentulous patients.2)No contraindication for implant surgery.3)Sufficient volume of bone in anterior region of the mandible.4)Patients who are able to understand and agree to participate by in the study.5)Patient is unsatisfied with the previous dentures.
|
|
| ExclusionCriteria |
| Details |
1)Patients with any local and systemic diseases are contraindicated for dental implants.2)Patients who chronically smoke, chew tobacco.3)Patients with conditions requiring chronic routine prophylactic use of antibiotics or prolonged use of steroids.4)Patients undergoing radiation therapy or chemotherapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To enhance retention of the mandibular complete denture by placing single implant at the symphysis region of the mandible |
at baseline, 1 months, 3 months, 6 months after loading the prosthesis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| oral health related quality of life and denture satisfaction |
2 years |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
28/10/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
The study is a randomized clinical follow up study to compare between conventional complete denture wearer and single mandibular overdenture wearer for enhanced mandibular overdenture retention at 6 months and evaluate oral health related quality of life and denture satisfaction between complete denture wearer and single mandibular implant overdenture at 2 years. |