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

Al-Azhar University

Status: Completed

Conditions: Periodontal Index; Mastication; Dental Plaque; Bleeding on Probing; Alveolar Bone Loss

Treatments: Device: Root form dental implant

Study type: Interventional

Funder types: Other

Identifiers

NCT06599450

AUAREC20210006-5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Male

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

One median implant

Active Comparator group

Description:

One median implant to retain mandibular complete overdenture

Treatment:

Device: Root form dental implant

One parasymphyseal implant

Active Comparator group

Description:

One parasymphyseal implant to retain mandibular complete overdenture

Treatment:

Device: Root form dental implant

Two implants

Active Comparator group

Description:

Two implants in the intraforaminal distance to retain mandibular complete overdenture

Treatment:

Device: Root form dental implant