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

NCT ID: NCT06965517

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2025-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Edentulous Jaw

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4 implants inserted in fully edentulous maxilla, then loading with ball abutments for maxillary overdenture
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
one of the study authors rather than the outcome assessors will take radiographic records and assess bone changes

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Digital group

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

Group Type ACTIVE_COMPARATOR

Maxillary implant supported overdenture , Digital jaw relation group

Intervention Type PROCEDURE

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

Static group

implant supported maxillary overdenture constructed using the conventional jaw relation method

Group Type PLACEBO_COMPARATOR

Maxillary implant supported overdenture , Static jaw relation group

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Maxillary implant supported overdenture , Digital jaw relation group

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

Intervention Type PROCEDURE

Maxillary implant supported overdenture , Static jaw relation group

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lamiaa Gouda Al-Shahier B-Eid AbdelMonem Saleh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lamiaa GA Saleh, BSc, MSc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Ain Shams University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Dentistry, Ain Shams University

Cairo, Cairo Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FDASU-RecID022140

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.