Single vs. Two Implants for Mandibular Overdentures (SIMO/TIMO)

Clinical and Radiographic Comparison of Symphyseal and Parasymphyseal Single Implant Versus Two Implants in Complete Mandibular Overdentures

This study aimed to compare the use of single implants in the symphyseal and parasymphyseal, and two implants were inserted in the canine area bilaterally to assist mandibular complete overdentures regarding clinical evaluation, marginal bone loss, and masticatory efficiency. The null hypothesis was that there was no statistically significant difference in clinical evaluation, marginal bone loss, and masticatory efficiency among single symphyseal implants, single parasymphyseal implants, and two-implant-assisted complete mandibular overdentures.

Study Overview

• Status: Completed
• Conditions: Dental Plaque; Alveolar Bone Loss; Mastication; Bleeding on Probing; Periodontal Index
• Intervention / Treatment: Device: Root form dental implant

Detailed Description

This randomized, controlled clinical trial compared the symphyseal and parasymphyseal single implants versus two implants in complete mandibular overdentures. Fifteen completely edentulous male patients (50-65 years) were chosen and randomly grouped into three equal groups (five patients in each) according to the position and number of the received implants to assist mandibular complete overdentures. Group I: single median implant. Group II: single parasymphyseal implant. Group III: two implants were inserted in the canine area bilaterally. After three months of osseointegration, the lower denture was transformed into an implant-assisted complete mandibular overdenture. Clinical observations were documented on the day of loading, three, six, and nine months later for each implant. Follow-up CBCT scans were performed to assess marginal bone loss on the day of loading, six and twelve months later. The masticatory efficiency evaluation was conducted one month and three months after loading.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assuit, Egypt
    • Faculty of Dental Medicine, Al-Azhar University, Assuit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients with a class I Maxillo-mandibular jaw relationship
• patients with residual ridges had normal morphology, were free from severe bony undercuts or flabby tissue, and were covered by firm mucoperiosteum.
• A cone beam CT of the lower arch was made to detect the presence of pathological lesions, remaining roots, or impacted teeth in the arch and evaluate both bone quality and quantity, especially in the area of interest

Exclusion Criteria:

• patients with current chemotherapy or radiotherapy, bleeding disorders, uncontrolled diabetes
• patients with a history of drug therapy that interferes with bone resorption or deposition (e.g., the prolonged use of glucocorticoids, antiresorptive medications, selective serotonin reuptake inhibitors, and proton-pump inhibitors),
• Those with any physical reasons that could affect follow-up, psychiatric problems, heavy smokers, drug or alcohol addicts, immunocompromised patients, abnormal jaw relationship, inadequate inter arch space.
• patients with temporomandibular disorders and para-functional habits (e.g., bruxing and clenching).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: One median implant; One median implant to retain mandibular complete overdenture	Device: Root form dental implant; Placement of titanium endosteal root form threaded tapered two-piece dental implant to assist mandibular complete overdenture
Active Comparator: One parasymphyseal implant; One parasymphyseal implant to retain mandibular complete overdenture	Device: Root form dental implant; Placement of titanium endosteal root form threaded tapered two-piece dental implant to assist mandibular complete overdenture
Active Comparator: Two implants; Two implants in the intraforaminal distance to retain mandibular complete overdenture	Device: Root form dental implant; Placement of titanium endosteal root form threaded tapered two-piece dental implant to assist mandibular complete overdenture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the plaque index	The presence and amount of plaque were determined at the four sites around the implant (mesial, distal, buccal, and lingual) and scored from zero to three. Grade 0: No plaque by probing. Grade 1: film of plaque detected by probing. Grade 2: Visible plaque with the naked eye. Grade 3: abundant soft material in the sulcus, mucosal margin, and adjacent implant surface.	The plaque index was documented at follow-up visits on the day of loading, three, six, and nine months later for each implant.
Change in the pocket depth	The pocket depth was measured by inserting a graduated plastic periodontal probe between the oral sulcular epithelium and the implant with minimal pressure at the midpoint of the four surfaces. The distance from the bottom of the sulcus to the mucosal margin was measured and recorded to the nearest millimeter; the mean of four readings was considered the pocket depth for this group at the chosen time	The pocket depth was documented at follow-up visits on the day of loading, three, six, and nine months later for each implant.
Change in the bleeding index	The bleeding index was assessed for the four surfaces while measuring the pocket depth if the bleeding was visible after probing within 20 seconds. It is typically scored as 0 (no bleeding), 1 (bleeding point), 2 (single line of blood), or 3 (heavy or profuse bleeding). The mean of four readings was considered the bleeding index for this group at the chosen time	The bleeding index was documented at follow-up visits on the day of loading, three, six, and nine months later for each implant.
Change in bone level around implant	Calculating average bone height involves dividing the sum of buccal, lingual, mesial, and distal bone height by 4. The real bone loss can be calculated by subtraction from the implant length	Immediately after loading, six months, and twelve months later
Change in the masticatory efficiency	The masticatory efficiency was assessed when the patient ate three different types of food (carrot, apple, and banana) with varying degrees of hardness, cut into standardized pieces (1 cm cube each). The collected data included the following measurements: the chewing stroke count before the first swallow, the chewing stroke count until the oral cavity is empty of food, the count of swallows until the oral cavity is empty of food, the time estimated in seconds until the first swallow, and the time estimated in seconds until the oral cavity is empty of food.	The masticatory efficiency was documented at follow-up visits one month and three months after the overdenture insertion

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Chair: Ahmed B El-okl, Professor, Removable Prosthodontics, Al-Azhar University, Asuit, EGY

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Tooth Diseases; Periodontal Atrophy; Dental Deposits; Bone Resorption; Dental Plaque; Alveolar Bone Loss
• Other Study ID Numbers: AUAREC20210006-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No