Clinical and Radiographic Evaluation of Implants in Protective Occlusion

Clinical and Radiographic Evaluation of Implants in Protective Occlusion in Comparison to Normal Occlusion In Molars. A 2 -Years Randomized Clinical Trial.

Occlusal overload may lead to a number of complications; biological and mechanical such as crestal bone loss, screw loosening, prosthetic fracture and even implant failure . Inadequate occlusal scheme (occlusion) causes occlusal overload increasing mechanical stresses which are transferred to the crestal bone and implant interface, leading to complications such as; Early implant failure, Early crestal bone loss, Intermediate to late implant failure, Intermediate to late implant bone loss, Screw loosening (abutment and prosthesis coping), Uncemented restoration, Component fracture, Porcelain fracture, Prosthesis fracture and Peri implant disease .Thus, a proper implant occlusal scheme plays a major role in the outcome of the implant treatment modality.

Study Overview

• Status: Completed
• Conditions: Implant Occlusion
• Intervention / Treatment: Procedure: Protective occlusion; Procedure: Maximum Intercusption

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • International Dental Continuing Education

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients who have a single posterior (1st or second molar) bounded implant with opposing natural tooth teeth.
• Adults above the age of 18.
• Good oral hygiene.
• Patient accepts to provide informed consent.

Exclusion Criteria:

• Smokers.
• Pregnant and lactating females.
• Medically compromised patients.
• Patients with untreated active periodontal diseases.
• Patients with parafunctional habits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Protective occlusion; According to the literature, Misch introduced the concept of implant-protective occlusion (IPO) (Misch and Bidez, 1994) based on basic prosthetic concepts, bone biomechanical principles and finite element analysis, which refers to an occlusal scheme designed for implant restoration, promoting the conditions for less biomechanical complications by reducing the stress to the implant interface and enhancing the longevity of the implant and prosthesis. It mainly entails the elimination of premature occlusal contacts or interferences.	Procedure: Protective occlusion; To evaluate crestal bone loss, chewing efficiency and prosthetic complications after single posterior implant restoration in protective occlusion in comparison to maximum intercuspation occlusion.
Experimental: Maximum Intercuspation	Procedure: Maximum Intercusption; to evaluate crestal bone loss, chewing efficiency and prosthetic complications after single posterior implant restoration in protective occlusion in comparison to maximum intercuspation occlusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal Bone Loss	• To evaluate marginal bone loss using bitewing radiographs in mm.	2 years
Stability	• to assess implant micromotion in both groups by resonance frequency analysis (Osstell®) in mm.	2 years

Collaborators and Investigators

• Sponsor: International Dental Contiuing Education

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Estimated): December 1, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Implant Occlusion, protective occlusion
• Other Study ID Numbers: IDCE-16112025

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