Effect of Digital Versus Static Jaw Relation Record on Crestal Bone Changes Around Implants Supporting Maxillary Single Overdenture

May 2, 2025 updated by: Lamiaa Gouda Al-Shahier B-Eid AbdelMonem Saleh, Ain Shams University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Conventional single upper denture will be made for all patients.
  • Occlusal adjustment of lower teeth for all patients by T-scan using the single upper conventional denture.
  • The single maxillary denture will be duplicated with radiopaque markers and CBCT will be used to determine the exact positions of the implants.

Surgical procedures

  1. Surgery will be done under local anesthesia.
  2. Drilling will be carried out under copious sterile irrigation.
  3. four implants will be inserted in canines and second premolar area in the maxilla.

After 3-4 months of implants placement, patients will be equally and randomly divided into 2 groups. Each group contains seven patients:

Digital group: For this group, implant supported maxillary overdenture will be constructed using electronic facebow to record maxillo-mandibular relation.

Static group: For this group, implant supported maxillary overdenture will be constructed using the conventional jaw relation method.

Post insertion:

  • Clinical evaluation for any signs of inflammation is made.
  • Further occlusal refining of lower teeth by T-scan is done with final overdenture.

Method of evaluation:

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistry, Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Digital group
implant supported maxillary overdenture constructed using electronic facebow to record maxillo-mandibular relation.
Procedure: Maxillary implant supported overdenture , Digital jaw relation group
implant supported maxillary overdenture constructed using electronic facebow to record maxillo-mandibular relation.
Placebo Comparator: Static group
implant supported maxillary overdenture constructed using the conventional jaw relation method
Procedure: Maxillary implant supported overdenture , Static jaw relation group
implant supported maxillary overdenture constructed using the conventional jaw relation method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal bone loss around implants
Time Frame: 18 month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
digital occlusal analysis using T-scan
Time Frame: 1 year
Immediately after implant overdenture insertion, occlusal force magnitude, time and equilibrium were measured by the T-scan digital system by instructing the patient to bite on a sensor attached to a laptop on which the biting force was displayed as a count of disocclusion time and occlusion time, dictating the degree of any occlusal interference. The system also shows the degree of centralization of biting force between the right and left sides of the arch.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Lamiaa GA Saleh, BSc, MSc, Faculty of Dentistry, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2022

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

April 15, 2025

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

May 2, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDASU-RecID022140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

the data will become available along with publishing the article

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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