| CTRI Number |
CTRI/2024/03/063788 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of biomarker and prosthetic complication in splinted and nonsplinted implant-supported prostheses |
|
Scientific Title of Study
|
A comparative evaluation of biological marker and prosthodontic complication in splinted and nonsplinted implant supported prostheses: A split mouth 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 |
Divya Dharshini M |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University |
| Address |
PG Clinic, 6th floor, Department of Prosthodontics Crown and Bridge, New dental building, Faculty of Dental Sciences, King Georges Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9994866606 |
| Fax |
|
| Email |
dr.divyadharshini23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mayank Singh |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
6th floor, Department of Prosthodontics Crown and Bridge, New Dental building, Faculty of Dental Sciences, King Georges Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9794713840 |
| Fax |
|
| Email |
dr_mayank1983@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Divya Dharshini M |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University |
| Address |
PG Clinic, 6th floor, Department of Prosthodontics Crown and Bridge, New Dental building, Faculty of Dental Sciences, King Georges Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9994866606 |
| Fax |
|
| Email |
dr.divyadharshini23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics Crown and Bridge, Faculty of Dental Sciences, King Georges Medical University, Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr. Divya Dharshini M |
| Address |
Department of Prosthodontics Crown and Bridges, Faculty of Dental Sciences, King Georges Medical University, Lucknow |
| Type of Sponsor |
Other [self funded ] |
|
|
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 Divya Dharshini M |
King Georges Medical University |
PG Clinic, 6th floor, Department of Prosthodontics Crown and Bridges, New Dental Building, Faculty of Dental Sciences, King Georges Medical University, Lucknow
Lucknow
UTTAR PRADESH |
9994866606
dr.divyadharshini23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ICD-10 K08 (Partially edentulous patients with bilaterally missing teeth Posterior region) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nonsplinted implant supported prostheses |
Following 3-5 months of healing, patients will be randomly restored on one side with Screw and Cement-retained (SCRP) splinted prostheses and SCRP nonsplinted implant supported prostheses on other side. Follow up will be done upto 6 months following prosthesis placement. |
| Intervention |
Splinted Implant supported prostheses |
Following 3-5 months of healing, patients will be randomly restored on one side with Screw and Cement-retained (SCRP) splinted prostheses and SCRP nonsplinted implant supported prostheses on other side. Follow up will be done upto 6 months following placement of prosthesis. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. At least two missing teeth on both sides in Posterior region of jaw.
2. Adequate bone height for accommodating two implants and to be placed at same appointment.
3. Patient without any dental pathologies and medical conditions.
4. Extraction is done at least 3-4 months prior to implant placement.
5. Restored with opposing dentition/implant in occlusion.
|
|
| ExclusionCriteria |
| Details |
1. Untreated caries/ Periodontal Diseases in Residual dentition.
2. Medically compromised patients (any past records of Uncontrolled Diabetes, radiation, Chemotherapy treatment, psychological problems ), Severe bruxism cases, and any TMD cases.
3. Patients under systemic corticosteroids or Bisphosphonates therapy.
4. Pregnant / Nursing at the time of enrollment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Clinical evaluation of probing depth
2. Radiographical evaluation of Marginal bone loss
3. Evaluation of levels of IL-1 Beta |
Baseline, 3rd month , 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prosthodontic Complications |
Baseline, 3rd month , 6th month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/03/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This
Prospective study is aimed to compare splinted and nonsplinted conventionally loaded Implants supported
prostheses restored with Screw- Cement Retained Prostheses (SCRP) system. AIMS AND OBJECTIVE:
The objective of the study will be to evaluate and compare the following
parameters in splinted and nonsplinted implant supported prostheses:
1. 1. Soft tissue health around the implant.
2. 2. Marginal bone Loss
3. 3. Level of IL-1β in the Peri-implant crevicular fluid (PICF)
4. 4. To Assess Prosthodontic complications such as fractured/chipped prosthesis, crown de-cementation, and/or
loosened abutment screw.
Study design: The present study will be designed as a Split-mouth
study, i.e. each patient will be treated as a Control group as well as a Test
group.
INTERVENTION:
Following 3-5 months of healing, patients will be randomly restored with Screw
and Cement-Retained prostheses (SCRP) non-splinted prostheses on
ipsilateral side, and splinted prostheses on contralateral side. For consistency, same type of abutment
will be used with internal hex connections. Post restoration of splinted and
nonsplinted implant supported prosthesis the parameters are evaluated at
Baseline, 3rd month and 6th month follow up period. |