| CTRI Number |
CTRI/2024/10/075058 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bone level changes around implant and bone loss in lower back region of edentulous bone in single and two implant supported overdentures in a comparative in-vivo study. |
|
Scientific Title of Study
|
Analysis of crestal bone level changes and posterior edentulous bone loss in conventionally loaded single and two implant supported overdentures an in-vivo 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 |
Neha |
| Designation |
Post Graduate student |
| Affiliation |
SGT University |
| Address |
Room no 103, Department of Prosthodontics, crown and bridge, Faculty of Dental Sciences, SGT University, Budhera, Gurugram-Badli road, Gurugram.
Gurgaon
HARYANA
122505
India |
| Phone |
8168676446 |
| Fax |
|
| Email |
nehagahlawat01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puja Malhotra |
| Designation |
Professor |
| Affiliation |
SGT University |
| Address |
Room no 103, Department of Prosthodontics, crown and bridge, Faculty of Dental Sciences, SGT University, Budhera, Gurugram-Badli road, Gurugram.
Gurgaon
HARYANA
122505
India |
| Phone |
9810857171 |
| Fax |
|
| Email |
DrPuja.fds@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puja Malhotra |
| Designation |
Professor |
| Affiliation |
SGT University |
| Address |
Room no 103, Department of Prosthodontics, crown and bridge, Faculty of Dental Sciences, SGT University, Budhera, Gurugram-Badli road, Gurugram.
Gurgaon
HARYANA
122505
India |
| Phone |
9810857171 |
| Fax |
|
| Email |
DrPuja.fds@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| Room number 103, Department of Prosthodontics and Crown and Bridge, Faculty of Dental Sciences, SGT University, Gurgaon-Badli road, Gurugram- 122505, India |
|
|
Primary Sponsor
|
| Name |
Neha |
| Address |
Room no 103, Department of Prosthodontics, Faculty of Dental Sciences, SGT University, Budhera, Gurugram-Badli road, Gurugram 122505 |
| 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 Neha |
SGT University |
Room no 103, Department of Prosthodontics and Crown and Bridge, Faculty of Dental Sciences, SGT University, Budhera, Gurugram-Badli road
Gurgaon
HARYANA |
8168676446
nehagahlawat01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-SGT Dental College, Hospital and Research Institute (IEC-SGTDCHRI) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M859||Disorder of bone density and structure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implant supported overdentures |
Single or Two implants will be placed in edentulous mandible in patients requiring complete dentures. |
| Comparator Agent |
Single vs two implant supported overdentures |
Crestal bone levels and posterior edentulous bone loss is measured at baseline and after 6 months and data is compared. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Anterior bone ridge width of minimum 4mm.
2. Anterior bone height of minimum 10mm.
3. Inter-occlusal distance of atleast 32mm.
4. Primary implant stability of 25 N-cm (Newton-centimetres) is achieved. |
|
| ExclusionCriteria |
| Details |
1.According to ASA Classification Class 3 and 4 patients.
2.Immunocompromised patients
3. Blood dyscrasias
4. Occlusal anomalies
5. Para-functional habits
6. Radiation therapy in orofacial region
7. Heavy smokers (more than 10 cigarettes per day)
8. Alcohol abusers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparative analysis of crestal bone level changes around implant and posterior edentulous bone loss in single and two implant supported overdenture group |
Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of bite force and patient satisfaction |
4 weeks |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/10/2024 |
| 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="1"
Months="6"
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 - NO
|
|
Brief Summary
|
The study is prospective interventional cohort study. Edentulism is a chronic condition affecting mostly the elderly population. A single implant support Overdenture, if found to be as effective as a two-implant retained overdenture, will be a boon for patients with compromised systemic conditions like chronic kidney diseases where traumatic surgeries are best avoided due to the risk of infections, bone lesions, bleeding risks, and altered drug metabolism. This study aims to evaluate and compare variations in crestal bone levels, bone loss in posterior edentulous mandible, patient satisfaction and biting force between single and two implant supported overdentures following conventional loading protocol. |