Complete Edentulism
Conditions
Keywords
Single Implant, Retention Force, Overdenture Retention, Ball and Socket, OT Equator, Mandibular Overdenture
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.
Detailed description
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.
Interventions
A single-implant-retained mandibular complete overdenture using an OT Equator attachment system for retention.
A single-implant-retained mandibular complete overdenture using a Ball and Socket attachment system for retention.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Force of Implant Overdentures (IODs) | 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) |
| Peri implant Soft Tissue Health (Peri Implant Probing Depth ) | 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. |
| Crestal bone level changes | 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 |
| Peri implant Soft Tissue Health {The Modified Plaque Index (mPI)}. | 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. |
| Peri implant Soft Tissue Health {The Modified Sulcular Bleeding Index (mSBI)}. | 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. |
Countries
Egypt
Outcome results
None listed