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Completed

NCT Number: NCT07804823

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

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.

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Key information

Conditions

Complete Edentulism

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Asyut, Egypt

About this study

This randomized clinical study is designed to compare two attachment systems used with single-implant-retained mandibular complete overdentures: the OT Equator and Ball and Socket attachment systems. The study will evaluate how these two attachment designs perform during routine use over a 12-month follow-up period.

Participants will receive a mandibular complete overdenture retained by a single implant placed in the mandibular anterior region. The overdenture will be connected to the implant using one of the two attachment systems under investigation. Participants will be followed regularly to assess changes in the retention of the overdenture over time.

The study is intended to provide clinical evidence regarding the performance and durability of these two commonly used attachment systems and to assist clinicians in selecting an appropriate attachment system for single-implant mandibular overdenture treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

OT Equator Attachment System

Device

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

Ball and Socket Attachment System

Device

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

Primary outcomes

  1. Retention Force of Implant Overdentures (IODs)

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

    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)

  2. Peri implant Soft Tissue Health (Peri Implant Probing Depth )

    Time frame: 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 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.

  3. Crestal bone level changes

    Time frame: 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.

    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

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

    Time frame: 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 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.

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

    Time frame: 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 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.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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