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

NCT06376019 | Completed DMC

• 1 other identifier: FDASU-RecID11352
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

• Assessment of occlusion/disocclusion time

  occlusion/disocclusion time will be evaluated using a T scan device

  3 months

Study Arms (3)

group CD (conventional complete denture group)

PLACEBO COMPARATOR

patients will receive a conventional complete denture with no implant placement

Procedure: complete denture

group IB (implant-supported overdenture with ball attachment)

ACTIVE COMPARATOR

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

Procedure: solitary Implant loading with ball attachment

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

ACTIVE COMPARATOR

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

Procedure: splinted Implant loading with intra oral welding

Interventions

solitary Implant loading with ball attachment PROCEDURE

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

group IB (implant-supported overdenture with ball attachment)

splinted Implant loading with intra oral welding PROCEDURE

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

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

complete denture PROCEDURE

Mucosa supported conventional complete denture will be fabricated without supporting implants

group CD (conventional complete denture group)

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, 11361, Egypt

Location

MeSH Terms

Conditions

Jaw, Edentulous

Interventions

Denture, Complete

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dentures; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Officials

• Ahmed MA Mohamed, BDS MSc MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: the statistician will be the only one to be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of oral and maxillofacial prosthodontics

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

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 19, 2024
• Study Start: April 25, 2024
• Primary Completion: August 15, 2024
• Study Completion: September 15, 2024
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

EG (1)