Comparison Between Single Implant Retained Partial Over-denture and Conventional Partial Denture

NCT03324789 | Unknown

• 1 other identifier: 9999
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Bone Loss in Jaw

Keywords

Single implant; Anterior edentulism; partial denture

Outcome Measures

Primary Outcomes (1)

• patient satisfaction

  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

  six months

Secondary Outcomes (1)

• Bone loss

  Nine months

Study Arms (2)

Single Implant Partial Over-denture

EXPERIMENTAL

The design will be as follows; two rests on principle abutments and lingual plate major connector, single implant in the symphyseal region.

Other: Single Implant Partial Over-denture

Conventional Partial Denture

ACTIVE COMPARATOR

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 .

Other: Conventional Partial Denture

Interventions

Single Implant Partial Over-denture OTHER

Single Implant Retained Partial Over-denture will be as follows; two rests on principle abutments and lingual plate major connector, single implant in the symphyseal region.

Single Implant Partial Over-denture

Conventional Partial Denture OTHER

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 .

Conventional Partial Denture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry-Cairo Uni

Giza, Egypt

Location

Study Officials

• Radwa Sheta

  Faculty of dentistry-Cairo Uni

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheta

CONTACT

+2001003866631; radwasheta9@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding will only be done for the outcome assessor for patient satisfaction and the statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 30, 2017
• Study Start: December 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 30, 2017

Record last verified: 2017-10

Locations

EG (1)