NCT05972538

Brief Summary

A Total number of 36 implants were installed in 6 patients having mandibular single denture. The patients were divided into two groups according to the definitive prosthesis. Group I received ball and socket retained mandibular implant overdenture while Group II received cement retained implant supported fixed bridges.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

July 17, 2023

Last Update Submit

July 25, 2023

Conditions

Complete Edentulism

Keywords

Implant stabilityPocket depthPatient SatisfactionOverdentures

Outcome Measures

Primary Outcomes (2)

  • Assessment of change in implant stability

    Assessment of implant stability by device ( Ostell device)

    on the 15th, 30th, 60th and 90th days of overdenture insertion

  • Assessment of change in implants clinical performance throughout the follow-up period.

    Assessment of change in pocket depth, plaque index and bleeding on probing) around the implant abutments. by periodontal probe.

    on the 15th, 30th, 60th and 90th days of over denture insertion.

Secondary Outcomes (1)

  • Assessment of patient satisfaction

    on the 90th day of prosthesis delivery

Study Arms (2)

Group I

ACTIVE COMPARATOR

patients received ball and socket retained mandibular implant overdentures restoring complete edentulous mandible.

Device: Osstell ( Osstell AB, Goteborg, Sweden).Device: periodontal probe (Vivacare, TPS, Vivadent, Schaan, LichtensteinOther: questionnaire for patient satisfaction

Group II

EXPERIMENTAL

patients received cement retained mandibular implant overdentures restoring complete edentulous mandible.

Device: Osstell ( Osstell AB, Goteborg, Sweden).Device: periodontal probe (Vivacare, TPS, Vivadent, Schaan, LichtensteinOther: questionnaire for patient satisfaction

Interventions

Osstell ( Osstell AB, Goteborg, Sweden).DEVICE

Implant stability were assessed on 15, 30,60 and 90 days of prosthesis delivery

Group IGroup II
periodontal probe (Vivacare, TPS, Vivadent, Schaan, LichtensteinDEVICE

Clinical evaluation included assessment of pocket depth, plaque index and bleeding on probing) around the implant abutments on 15, 30,60 and 90 days of prosthesis delivery

Also known as: - Assessment of implants clinical performance
Group IGroup II
questionnaire for patient satisfactionOTHER

A questionnaire was used to evaluate patient satisfaction on 90 days at the end of follow up period.

Group IGroup II

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • highly co-operative
  • non-smoker
  • systemically free from any chronic diseases

You may not qualify if:

  • immunocompromised patients
  • patients having knife edge, flat or flabby ridge,
  • patients having T. M. J disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Research Centre

Cairo, Dokki, 12622, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Asmaa N. Elboraey, Asso, Prof

    National Research Centre, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants don't know which treatment type they received.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two groups.Group I received ball and socket retained mandibular implant overdenture while Group II received cement retained implant supported fixed bridges
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 17, 2023

First Posted

August 2, 2023

Study Start

April 1, 2023

Primary Completion

July 1, 2023

Study Completion

July 5, 2023

Last Updated

August 2, 2023

Record last verified: 2023-07

Locations

EG(1)