NCT07256379

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 1, 2025

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

2.7 years

First QC Date

November 20, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

Implant Occlusion, protective occlusion

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Protective occlusion

ACTIVE COMPARATOR

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

Maximum Intercuspation

EXPERIMENTAL
Procedure: Maximum Intercusption

Interventions

to evaluate crestal bone loss, chewing efficiency and prosthetic complications after single posterior implant restoration in protective occlusion in comparison to maximum intercuspation occlusion.

Maximum Intercuspation

To evaluate crestal bone loss, chewing efficiency and prosthetic complications after single posterior implant restoration in protective occlusion in comparison to maximum intercuspation occlusion.

Protective occlusion

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Dental Continuing Education

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 1, 2025

Study Start

September 1, 2022

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations