Different Implant Positions for Implant Retained Mandibular Overdenture

Sponsor

Mansoura University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06055842

Collaborator

(none)

Enrollment

Location

Arms

3.3

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Loss	Other: over-denture	N/A

Detailed Description

Twelve patients will be recruited from a previous study (14), having two-implant mandibular overdentures. Patients recalled from the database set of the clinic of the Removable Prosthodontic Department, Faculty of Dentistry, Mansoura University. The patients will be grouped based on the position of the two implants.

All patients will be informed about all prosthetic procedures that will be done. Also, they will sign the consent form of the ethical committee of the faculty of dentistry, at Mansoura University.

All selected patients with the following criteria: mandibular two implants retained overdenture opposing complete edentulous maxillary arch, attended the previous follow-up recalls with previous CBCT examination. Patients who didn't attend previous follow-up recalls, didn't perform radiographic follow-up, or had para-functional habits will excluded from the study Patients will be divided into two groups Group A (6 patients): Patients having two mandibular implants in lateral incisor positions.

Group B (6 patients): Patients having two mandibular implants in canine positions.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Retrospective Study on the Effect of Different Implant Positions for Implant Retained Mandibular Overdenture: Radiographic Evaluation of the Circumferential Bone Level and Bone Remodeling in the Anterior and Posterior Mandible

Actual Study Start Date :

Aug 23, 2023

Anticipated Primary Completion Date :

Oct 12, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: lateral incisor group Patients having two mandibular implants in lateral incisor positions.	Other: over-denture implant retained overdenture prosthesis.
Active Comparator: canine group Patients having two mandibular implants in canine positions	Other: over-denture implant retained overdenture prosthesis.

Arm

Intervention/Treatment

Active Comparator: lateral incisor group

Patients having two mandibular implants in lateral incisor positions.

Other: over-denture

implant retained overdenture prosthesis.

Active Comparator: canine group

Patients having two mandibular implants in canine positions

Other: over-denture

implant retained overdenture prosthesis.

Outcome Measures

Primary Outcome Measures

implant survival rate [5 years]
index
circumferential bone loss [5 years]
peri-implant bone changes in mm
posterior bone changes [5 years]
bone loss in mm

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Khloud Ezzat	Mansoura		Egypt	54790

Sponsors and Collaborators

Mansoura University

Investigators

Principal Investigator: Khloud Ezzat, Lecturer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mansoura University

ClinicalTrials.gov Identifier:

NCT06055842

Other Study ID Numbers:

M0108023RP

First Posted:

Sep 28, 2023

Last Update Posted:

Oct 3, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mansoura University

implant

overdenture

Study Results

No Results Posted as of Oct 3, 2023