NCT06965517

Brief Summary

patients will be equally and randomly divided into 2 groups. Each group contains seven patients: Digital Group: implant supported maxillary overdenture will be constructed using electronic facebow to record maxillo-mandibular relation. Static Group: implant supported maxillary overdenture will be constructed using the conventional jaw relation method. Radiographic evaluation for crestal bone height around implants using direct digital periapical paralleling cone technique. All data of radiographic evaluation were collected and tabulated then statistically analyzed using SPSS software.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration 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

November 30, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
Last Updated

May 11, 2025

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

April 15, 2025

Last Update Submit

May 2, 2025

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

  • Marginal bone loss around implants

    Crestal bone changes around implants supporting maxillary single overdenture opposed by natural dentition were measured using periapical radiography through long cone technique

    18 month

Secondary Outcomes (1)

  • digital occlusal analysis using T-scan

    1 year

Study Arms (2)

Digital group

ACTIVE COMPARATOR

implant supported maxillary overdenture constructed using electronic facebow to record maxillo-mandibular relation.

Procedure: Maxillary implant supported overdenture , Digital jaw relation group

Static group

PLACEBO COMPARATOR

implant supported maxillary overdenture constructed using the conventional jaw relation method

Procedure: Maxillary implant supported overdenture , Static jaw relation group

Interventions

Maxillary implant supported overdenture , Digital jaw relation groupPROCEDURE

implant supported maxillary overdenture constructed using electronic facebow to record maxillo-mandibular relation.

Digital group
Maxillary implant supported overdenture , Static jaw relation groupPROCEDURE

implant supported maxillary overdenture constructed using the conventional jaw relation method.

Static group

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: under 60 years.
  • Completely edentulous maxillary arch.
  • Opposing natural dentition in the mandibular arch.
  • Residual mandibular ridge has adequate bone and covered by firm healthy mucosa.
  • Class I maxillary-mandibular relationship.
  • Normal salivary flow with normal viscosity.
  • Systemically free patients.

You may not qualify if:

  • Patients with poor oral hygiene.
  • Patients with abnormal oral habits as (bruxism, clenching, tongue thrusting).
  • Bone or mucosal diseases.
  • Metabolic diseases or uncontrolled diabetes and TMJ disorders.
  • Conditions that may complicate the treatment like; large tongue, gagging reflex and limited mouth opening.
  • Patients who are smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Officials

  • Lamiaa GA Saleh, BSc, MSc

    Faculty of Dentistry, Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
one of the study authors rather than the outcome assessors will take radiographic records and assess bone changes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 4 implants inserted in fully edentulous maxilla, then loading with ball abutments for maxillary overdenture
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 15, 2025

First Posted

May 11, 2025

Study Start

November 30, 2022

Primary Completion

January 1, 2025

Study Completion

April 15, 2025

Last Updated

May 11, 2025

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

a data availability statement will be provided in the article going to be published indicating that data will be available upon reasonable request from the principle investigator

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
the data will become available along with publishing the article

Locations

EG(1)