Occlusion and Dis-Occlusion Time in Mandibular Overdentures Supported by Conventional Versus Mini- Dental Implants

NCT07256106 | Recruiting DMC

• 1 other identifier: FDASU-RECIR072505
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study will be comparing between the occlusion and disocclusion time in mandibular single overdenture supported with immediately loaded two conventional implants versus immediately loaded four mini-implants. Research question Is there a difference in occlusion and disocclusion time between two mandibular single dentures, one supported by immediately loaded two conventional implants and the second one supported by immediately loaded four mini-implants? Primary outcome: occlusion and disocclusion time Secondary outcome: Kapur index The null hypothesis is that there is no difference between both treatment modalities on occlusion and disocclusion time.

Conditions

Dental Implant; Edentulous Mouth

Keywords

occlusion time; disocclusion time

Outcome Measures

Primary Outcomes (1)

• occlusion/dis occlusion time

  Occlusal parameters: occlusion time (OT) and disocclusion time (DT) will be recorded for each patient. The patient will be asked to close on sensor in centric occlusion holding their teeth together for 1 to 3 seconds then start right eccentric movement until disoccluding their teeth. This will be repeated 4 times for the right excursion (DT-right) and 4 times for the left excursion (DT-left). OT, DT-right, and DT-left were then calculated by taking the averages of the recordings.

  1 year

Secondary Outcomes (1)

• denture stability

  1 year

Study Arms (2)

conventional implant supported mandibular overdenture

ACTIVE COMPARATOR

Group CI patients will be rehabilitated with mandibular overdentures retained by two immediately loaded conventional implants inserted in the inter-foraminal region.

Procedure: conventional dental implant

mini-implant supported mandibular overdenture

EXPERIMENTAL

Group MI patients will be rehabilitated with single mandibular overdentures retained by four immediately loaded mini implants inserted in the inter-foraminal region.

Procedure: mini dental implant

Interventions

mini dental implant PROCEDURE

For group MI patient, four screw type one piece mini dental implants will be inserted in the predetermined implant sites in the symphesial region. The position of the two distal implants will be marked 6 mm mesial to each mental foramen. The position of the other two implants will be marked equidistant from the distal implants with and at least 5 mm apart

mini-implant supported mandibular overdenture

conventional dental implant PROCEDURE

For group CI patient, two screw type conventional implants will be inserted in the symphesial region.

conventional implant supported mandibular overdenture

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with completely edentulous mandibular ridges and fully dentate or partially dentate maxillary arch restored with fixed restoration,
• enough inter-arch space to allow for prosthetic rehabilitation with lower implant-retained overdentures
• good oral hygiene and motivation.

You may not qualify if:

• The excluded patients will be patients with major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus, pregnancy, patients under bisphosphonate treatment.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Faculty of Dentistry Ain Shams University

Cairo, 11361, Egypt

RECRUITING

Faculty of Dentistry Ain Shams University

Cairo, 11361, Egypt

RECRUITING

MeSH Terms

Conditions

Mouth, Edentulous

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Ahmed Mohamed, MD

  Faculty of dentistry, ain shams university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmed mohamed, MD

CONTACT

01111191337; ahmedmostafa@dent.asu.edu.eg

marwa kothayer, MD

CONTACT

01224848537; marwakothayer@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking of the outcome assessor the one responsible for measuring the occlusion/dis occlusion time
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor , faculty of dentistry

Model Details: Randomized Controlled Trial (RCT) with parallel assignment of the participants in two groups in ratio 1:1. Randomization will be guided by a computer-generated list. Both groups will be placed in twenty eight numbered closed opaque sealed envelopes according to the computer generated list of random numbers and an envelope will be allocated to each patient. For allocation concealment, one of the postgraduate students who will be the only one to know the key so that the authors and the patients won't know in which group the patient will be. Afterwards, the authors will be informed by the randomization to be tabulated.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: November 29, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 15, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

EG (2)