Occlusion and Disocclusion Time in Immediately Loaded Overdentures Supported by Two Splinted Versus Non Splinted Interforaminal Implants

NCT ID: NCT06376019

Last Updated: 2025-08-07

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-25

Study Completion Date

2024-09-15

Brief Summary

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

complete denture wearers struggle to eat well with their dentures due to poor denture retention, stability, and occlusal disharmony. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture.

Detailed Description

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

The gold standard treatment for completely edentulous patients is a removable complete denture, which satisfies patients functional and aesthetic requirements at a low cost. However, the main problem associated with a complete denture is the instability of the complete removable denture, especially the mandibular one. Implant-assisted overdentures over two or three implants are used as a treatment option to increase stability, function, and retention of the denture at a reasonable cost. The immediate loading protocol allows the placement of temporary restoration on the day of implant placement surgery. Pierluigi Mondani pioneered intraoral welding in the early 1970s as an approach to load patients immediately with resin prosthesis and weld titanium implants to a titanium bar in their mouths. The technique of intraoral welding provides rigid splinting in cases of immediate implant loading. Occlusal loads and stability of occlusion are important to consider in the immediate loading of implants to avoid implant biomechanical failures, marginal bone loss, or even complete loss of osseointegration. Quantitative analyzers like t-scans, which are pressure-sensitive films, and virtual technology give a precise method of assessing the sequence of time and occlusal contact force magnitude by converting qualitative data into quantitative parameters. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture.

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

parallel assignment of the participants in ratio 1:1:1 will take place. For allocation concealment, opaque sealed envelopes will be used.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

the statistician will be the only one to be blinded

Study Groups

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

group CD (conventional complete denture group)

patients will receive a conventional complete denture with no implant placement

Group Type PLACEBO_COMPARATOR

complete denture

Intervention Type PROCEDURE

Mucosa supported conventional complete denture will be fabricated without supporting implants

group IB (implant-supported overdenture with ball attachment)

patients will receive an implant-supported overdenture with ball attachment. The overdenture will be relined by a soft liner.

Group Type ACTIVE_COMPARATOR

solitary Implant loading with ball attachment

Intervention Type PROCEDURE

ball attachment will be attached to the dental implant on the day of implant placement

group II (implant-supported overdenture with an intraoral welded bar)

patients will receive an implant-supported overdenture with an intraoral welded bar. The overdenture will be relined by a soft liner.

Group Type ACTIVE_COMPARATOR

splinted Implant loading with intra oral welding

Intervention Type PROCEDURE

Titanium bar will be welded to the dental implant on the day of implant placement

Interventions

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

solitary Implant loading with ball attachment

ball attachment will be attached to the dental implant on the day of implant placement

Intervention Type PROCEDURE

splinted Implant loading with intra oral welding

Titanium bar will be welded to the dental implant on the day of implant placement

Intervention Type PROCEDURE

complete denture

Mucosa supported conventional complete denture will be fabricated without supporting implants

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* completely edentulous patients
* non-smokers
* good oral hygiene
* motivated patients

Exclusion Criteria

* major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus
* the need for extensive bone grafting in planned implant site
* pregnancy
* patients under bisphosphonate treatment
* limited mouth-opening for executing the implant surgery.
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 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.

Ahmed Mostafa Abdelfatah

associate professor of oral and maxillofacial prosthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Ahmed MA Mohamed, BDS MSc MD

Role: PRINCIPAL_INVESTIGATOR

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, , 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-RecID11352

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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