Comparison Between OT-Equator Versus Ball and Socket Attachment Systems in Implant-Retained Mandibular Complete Overdentures

NCT07804823 | Completed

• 1 other identifier: AUAREC20240005-3
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two different attachment systems, OT Equator and Ball and Socket, used to retain mandibular complete overdentures supported by a single dental implant. The study aims to evaluate and compare the retention of the two attachment systems over a 12-month follow-up period. The study will help determine whether one attachment system provides better and more stable retention of the overdenture over time.

Conditions

Complete Edentulism

Keywords

Single Implant; Retention Force; Overdenture Retention; Ball and Socket; OT Equator; Mandibular Overdenture

Outcome Measures

Primary Outcomes (5)

• Retention Force of Implant Overdentures (IODs)

  Retention force measured using a digital force gauge to quantify the dislodgement force required to remove the overdenture from the implants. Measurements will be reported in Newtons (N)

  Time Frame: Baseline (immediately after overdenture pick-up), 3 months, 6 months, and 12 months.

• Peri implant Soft Tissue Health (Peri Implant Probing Depth )

  Peri implant soft tissue health assessed using the Peri Implant Probing Depth (PIPD). Peri-implant probing depth (PIPD) is defined as the distance from the peri-implant mucosal margin to the base of the sulcus. Clinical measurements were performed using a standardized periodontal probe with a 0.5-mm diameter tip.

  Assessments performed over an 12 month total follow up period, at the following intervals: Immediately after pick up (baseline), 3 months, 6 months, and 12 months.

• Crestal bone level changes

  Crestal bone levels measured on standardized periapical radiographs taken with a paralleling technique. Bone level is defined as the distance from the implant shoulder to the first bone to implant contact

  Radiographic measurements performed over an 12 month total follow up period, at the following intervals: 1 - Immediately after pick up (baseline) 2 - 3 months 3 - 6 months 4 - 12 months.

• Peri implant Soft Tissue Health {The Modified Plaque Index (mPI)}.

  Peri implant soft tissue health assessed using the Modified Plaque Index (mPI). Dental plaque accumulation was assessed using the modified plaque index. Clinical measurements were performed using a standardized periodontal probe with a 0.5-mm diameter tip. The presence and amount of plaque were determined at 4 sites per implant (in the middle of the four surfaces: buccal, lingual, mesial, and distal) and scored from 0 to 3. SCORE 0: No plaque detection. SCORE 1: film of plaque detected by probing. SCORE 2: plaque seen with the naked eye. SCORE 3: abundance of soft matter within the sulcus, gingival margin, and adjacent implant surface.

  Assessments performed over an 12 month total follow up period, at the following intervals: Immediately after pick up (baseline), 3 months, 6 months, and 12 months.

• Peri implant Soft Tissue Health {The Modified Sulcular Bleeding Index (mSBI)}.

  Peri implant soft tissue health assessed using the Modified Sulcular Bleeding Index (mSBI).The inflammatory status of the peri-implant soft tissues was assessed using the Modified Sulcular Bleeding Index (mSBI). Clinical measurements were performed using a standardized periodontal probe with a 0.5-mm diameter tip. Bleeding response was evaluated at six sites per implant: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual and scored as follows: SCORE 0: No bleeding. SCORE 1: Isolated bleeding spots visible. SCORE 2: Blood forms a confluent red line on margin. SCORE 3: Heavy or profuse bleeding.

  Assessments performed over an 12 month total follow up period, at the following intervals: Immediately after pick up (baseline), 3 months, 6 months, and 12 months.

Study Arms (2)

OT Equator Group

EXPERIMENTAL

Participants will receive a mandibular complete overdenture retained by a single dental implant using an OT Equator attachment system.

Device: OT Equator Attachment System

Ball and Socket Group

EXPERIMENTAL

Participants will receive a mandibular complete overdenture retained by a single dental implant using a Ball and Socket attachment system.

Device: Ball and Socket Attachment System

Interventions

OT Equator Attachment System DEVICE

A single-implant-retained mandibular complete overdenture using an OT Equator attachment system for retention.

OT Equator Group

Ball and Socket Attachment System DEVICE

A single-implant-retained mandibular complete overdenture using a Ball and Socket attachment system for retention.

Ball and Socket Group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completely edentulous patients
• Non smokers
• Patients free from intra oral diseases that may affect implant overdenture prognosis
• Patients free from systemic conditions that may influence bone resorption or implant success
• Able and willing to comply with study visits and follow up schedule

You may not qualify if:

• Smokers or tobacco users
• Presence of active oral lesions, infections, or mucosal pathology
• Systemic diseases affecting bone metabolism (e.g., uncontrolled diabetes, osteoporosis requiring bisphosphonates)
• History of head and neck radiation
• Severe parafunctional habits (e.g., bruxism)
• Inability to attend follow up appointments or provide informed consent

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of Dental Medicine, Al-Azhar University, (Assiut)

Asyut, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Removable Prosthodontics

Model Details: Participants will be randomly assigned to one of two parallel intervention groups. Each group will receive a mandibular complete overdenture retained by a single dental implant using either an OT Equator or a Ball and Socket attachment system. The groups will be followed prospectively for 12 months and compared with respect to overdenture retention.

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 4, 2026
• Study Start: October 1, 2024
• Primary Completion: March 30, 2026
• Study Completion: May 30, 2026
• Last Updated: September 4, 2026

Record last verified: 2026-08

Locations

EG (1)