Impact of Two Occlusal Schemes in Implant Retained Mandibular Overdenture on the Masticatory Efficiency

NCT06784050 | Completed Phase 2

• 1 other identifier: IRB00012891#133
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To assess the effect of two different occlusal schemes, bilateral balance and monoplane on the masticatory efficiency in mandibular implant retained overdenture with ball and socket attachment. Methodology: Twelve male completely edentulous patients were recruited for this clinical study. Each patient received two implants after that. Patients were divided randomly into two equal groups according to occlusal schemes which involved bilateral balanced occlusion and mono plane occlusion. each. Group 1 received a bilateral balanced occlusion scheme denture; Group 2 received monoplane occlusal scheme denture. Masticatory efficiencies were evaluated by assessing chewing time and number of chewing strokes with different types of foods. The data were collected, tabulated and statistically analyzed. Results: using dentures with bilateral balanced occlusion showed lower masticatory efficiency than the denture with monoplane occlusion with no significant difference when using soft food during the first month, while after 3 months there were significant differences between the two groups. Conclusion: The two-implant retained mandibular overdenture with monoplane occlusion showed relatively improved masticatory efficiency than with bilateral balanced occlusion.

Conditions

Edentulous Alveolar Ridge

Keywords

dental implant overdenture; occlusal scheme; masticatory efficiency

Outcome Measures

Primary Outcomes (2)

• Masticatory Efficiency Using Soft Food

  The masticatory efficiency was assessed by measuring the number of chewing strokes and the time taken to achieve the first swallow and complete mouth clearance while chewing standardized pieces of soft food.

  Assessments were made at three points, baseline, after one month and three months from the start of using the overdentures.

• Masticatory Efficiency Using Hard Food

  Similar to the soft food assessment, the efficiency for chewing hard food was evaluated by counting the number of chewing strokes and timing the duration until the first swallow and until the mouth was cleared of food.

  Assessments were made at three points, baseline, after one month and three months from the start of using the overdentures.

Study Arms (2)

Bilateral Balanced Occlusion Group

ACTIVE COMPARATOR

This group received dentures designed with a bilateral balanced occlusion scheme. This occlusion scheme aims for simultaneous contact of teeth across the dental arch during jaw movements, purported to enhance stability and comfort.

Procedure: Bilateral Balanced Occlusion

Monoplane Occlusion Group

EXPERIMENTAL

This group received dentures designed with a monoplane occlusion scheme. This scheme involves a flat occlusal plane without curvature, intended to reduce the complexity of denture fabrication and potentially improve masticatory efficiency by simplifying the occlusal contacts

Procedure: Monoplane Occlusion

Interventions

Bilateral Balanced Occlusion PROCEDURE

Dentures designed under this scheme feature a fully bilateral balanced articulation, ensuring bilateral, simultaneous contact of the anterior and posterior denture teeth in both centric and eccentric positions. This occlusal scheme is aimed at promoting stability and functionality of the dentures during various mandibular movements.

Bilateral Balanced Occlusion Group

Monoplane Occlusion PROCEDURE

This scheme utilizes zero-degree teeth to create a flat occlusal plane, which is designed to simplify the occlusal contacts and minimize the transmission of lateral forces during mastication. The aim is to improve masticatory efficiency by reducing the complexity of tooth contact

Monoplane Occlusion Group

Eligibility Criteria

• Age: 55 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male patients Completely edentulous Ages range from 55-60 years Residual alveolar ridges of maxilla and mandible covered by healthy, firm, compressible mucosa Free from any temporomandibular joint disorders Have Angle's class I jaw relation Edentulous mandible for at least 6 months No bone augmentation requirement Good oral hygiene

You may not qualify if:

• Presence of any systemic conditions that could compromise implant surgery History of chemotherapy or radiotherapy to the head and neck region History of taking bisphosphonates Heavy smoker status

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

outpatient clinic of the Prosthodontic Department, Faculty of Oral and Dental Medicine, Ahram Canadian University.

Cairo, Cairo Governorate, 11277, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 20, 2025
• Study Start: September 22, 2024
• Primary Completion: November 20, 2024
• Study Completion: December 20, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

EG (1)