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Clinical Trials/CTRI/2024/03/063788
CTRI/2024/03/063788CompletedUnknown

A comparative evaluation of biological marker and prosthodontic complication in splinted and nonsplinted implant supported prostheses: A split mouth study

Dr. Divya Dharshini M1 site in 1 country20 target enrollmentStarted: March 20, 2024Last updated:

Trial Snapshot

Phase
Unknown
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
1. Clinical evaluation of probing depth

Study Overview

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 restorationof splinted and nonsplinted implant supported prosthesis the parameters are evaluated at Baseline, 3rd month and 6th month follow up period.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • At least two missing teeth on both sides in Posterior region of jaw.
  • Adequate bone height for accommodating two implants and to be placed at same appointment.
  • Patient without any dental pathologies and medical conditions.
  • Extraction is done at least 3-4 months prior to implant placement.
  • Restored with opposing dentition/implant in occlusion.

Exclusion Criteria

  • Untreated caries/ Periodontal Diseases in Residual dentition.
  • Medically compromised patients (any past records of Uncontrolled Diabetes, radiation, Chemotherapy treatment, psychological problems ), Severe bruxism cases, and any TMD cases.
  • Patients under systemic corticosteroids or Bisphosphonates therapy.
  • Pregnant / Nursing at the time of enrollment.

Outcomes

Primary Outcomes

1. Clinical evaluation of probing depth

Time Frame: Baseline, 3rd month , 6th month

2. Radiographical evaluation of Marginal bone loss

Time Frame: Baseline, 3rd month , 6th month

3. Evaluation of levels of IL-1 Beta

Time Frame: Baseline, 3rd month , 6th month

Secondary Outcomes

  • Prosthodontic Complications(Baseline, 3rd month , 6th month)

Investigators

Sponsor
Dr. Divya Dharshini M
Sponsor Class
Other [self funded ]
Responsible Party
Principal Investigator
Principal Investigator

Divya Dharshini M

King Georges Medical University

Study Sites (1)

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