NCT06055842

Brief Summary

This study will aim to evaluate the effect of two different implant positions, lateral incisors, and canine areas, on anterior and posterior ridge resorption and bone remodeling after different periods of denture insertion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 7, 2025

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

September 20, 2023

Last Update Submit

January 5, 2025

Conditions

Bone Loss

Keywords

implantoverdenture

Outcome Measures

Primary Outcomes (3)

  • implant survival rate

    index

    5 years

  • circumferential bone loss

    peri-implant bone changes in mm

    5 years

  • posterior bone changes

    bone loss in mm

    5 years

Study Arms (2)

lateral incisor group

ACTIVE COMPARATOR

Patients having two mandibular implants in lateral incisor positions.

Other: over-denture

canine group

ACTIVE COMPARATOR

Patients having two mandibular implants in canine positions

Other: over-denture

Interventions

over-dentureOTHER

implant retained overdenture prosthesis.

canine grouplateral incisor group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mandibular two implants retained overdenture opposing complete edentulous maxillary arch,
  • attended the previous follow-up recalls with previous CBCT examination.

You may not qualify if:

  • Patients who didn't attend previous follow-up recalls, didn't perform radiographic follow-up, or had para-functional habits will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khloud Ezzat

Al Mansurah, 54790, Egypt

Location

Related Publications (1)

  • Mourad KE, Emera RMK, Habib A. Effect of different implant positions for two implant-retained mandibular overdenture: a retrospective 5-years radiographic evaluation of the circumferential peri-implant bone loss and posterior ridge resorptive changes. BMC Oral Health. 2024 Sep 30;24(1):1161. doi: 10.1186/s12903-024-04871-w.

    PMID: 39350107DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Denture, Overlay

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DenturesDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Officials

  • Khloud Ezzat

    Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

September 20, 2023

First Posted

September 28, 2023

Study Start

August 23, 2023

Primary Completion

October 12, 2023

Study Completion

December 1, 2023

Last Updated

January 7, 2025

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)