A comparative evaluation of biological marker and prosthodontic complication in splinted and nonsplinted implant supported prostheses: A split mouth study
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
Divya Dharshini M
King Georges Medical University