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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
18
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.
Faculty of Dental Medicine, Al-Azhar University, (Assiut)
Asyut, Egypt
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: 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.
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.
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
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.
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.
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.
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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.
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.