Comparative Study Between Single Implant Retained Partial Over-denture and Conventional Partial Denture in Mandibular Long Span Kennedy Class IV ( Randomized Clinical Trial )
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- patient satisfaction
Study Overview
Brief Summary
In this study we are going to evaluate patient satisfaction as well as the amount of bone loss on using single implant retained partial over-denture versus conventional partial denture for treatment of mandibular Kennedy class IV cases
Detailed Description
All the procedures will be made in the outpatient clinic of the removable prosthodontics department, faculty of oral medicine, Cairo University except the CBCT will be performed in the Oral radiology department, faculty of oral medicine, Cairo University.
The selected patients will be informed of the nature of the research work and informed consent will be signed by each one of them. Only motivated patients who showed co-operation will participate in the study. Patients will be randomly divided into 2 groups.
Clinical examination and investigations will be carried out for the eligible patients including TMJ examination and intraoral examination for oral mucosa. Diagnostic charts will be prepared with full medical and dental history as well as radiographic records. The upper and lower study casts were mounted on a semi-adjustable articulator to evaluate the interarch space and the occlusal plane.
Abutment teeth will be evaluated regarding mobility, caries, existing restoration, over eruption, and malalignment. Pocket depth around the abutment teeth will be measured buccally, lingually, and proximally. Radiographic evaluation of all abutment teeth will be carried out to assess the amount of bone support, crestal bone height, continuity of lamina dura, periapical pathosis, crown/root ratio, and root form. Panoramic radiograph also to evaluate the bone quality and quantity in the lower anterior region.
All the patients will be motivated for meticulous oral hygiene.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Blinding will only be done for the outcome assessor for patient satisfaction and the statistician
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Mandibular long span Kennedy class IV patients
- •Patients with full set of opposing dentition
- •Patients having enough implant bone height
- •No apparent bony mal-relation.
- •No intraoral soft or hard tissue pathosis
- •No uncontrolled systemic diseases such as hypertension, diabetes and immunodeficiency.
Exclusion Criteria
- •Drug or alcohol abuse
- •A health condition precluding surgery
- •Physical reasons that could affect follow-up
- •Psychiatric problems
- •Disorders to the implant area related to a history of radiation therapy to the head and neck, neoplasia, or bone augmentation to the implant site.
- •Heavy smokers
Arms & Interventions
Single Implant Partial Over-denture
The design will be as follows; two rests on principle abutments and lingual plate major connector, single implant in the symphyseal region.
Intervention: Single Implant Partial Over-denture (Other)
Conventional Partial Denture
patients will receive conventional partial denture with double Aker clasp on mandibular second premolar and first molar, with no indirect retention and lingual plate as major connector .
Intervention: Conventional Partial Denture (Other)
Outcomes
Primary Outcomes
patient satisfaction
Time Frame: six months
will be measured using Visual Analogue Scale (VAS) , represented by a horizontal line 100 mm in length where the patient marks on the line the point that best represents their current state where the severity increases from the left to the right side of the line \& it's degree is marked according to their answers to a questionnaire of five questions prepared on how well satisfied they are with the new treatment they are receiving
Secondary Outcomes
- Bone loss(Nine months)
Investigators
Radwa Ahmed Abdel Wanis
principal investigator
Cairo University