Single vs. Two Implants for Mandibular Overdentures

NCT06599450 | Completed

• 1 other identifier: AUAREC20210006-5
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

One median implant

ACTIVE COMPARATOR

One median implant to retain mandibular complete overdenture

Device: Root form dental implant

One parasymphyseal implant

ACTIVE COMPARATOR

One parasymphyseal implant to retain mandibular complete overdenture

Device: Root form dental implant

Two implants

ACTIVE COMPARATOR

Two implants in the intraforaminal distance to retain mandibular complete overdenture

Device: Root form dental implant

Interventions

Root form dental implant DEVICE

Placement of titanium endosteal root form threaded tapered two-piece dental implant to assist mandibular complete overdenture

One median implant; One parasymphyseal implant; Two implants

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of Dental Medicine, Al-Azhar University, Assuit

Asyut, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss; Dental Plaque

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Study Officials

• Ahmed B El-okl, Professor

  Removable Prosthodontics, Al-Azhar University, Asuit, EGY

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: January 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)