Crestal Bone Loss in Mandibular Telescopic Overdentures. Overdenture with Milled Titanium, Milled Poly-ether Ketone Ketones and 3D Printed Chrome Cobalt Secondary Copings.

NCT ID: NCT06639893

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-10-01

Brief Summary

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The objective of this clinical trial is to evaluate crestal bone loss every three months at time of overdenture insertion, 3, 6, 9, 12 months from overdenture use. Also, to evaluate prosthesis satisfaction.

All participants will receive conventional complete dentures, followed by two intraforaminal implants. After healing time, fabrication of secondary copings in all cases according to randomized groups for final overdenture insertion.

Detailed Description

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Conditions

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Telescopic Overdentures Dental Implants Customized Abutments

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Milled Titanium secondary copings

Group Type ACTIVE_COMPARATOR

Telescopic overdenture

Intervention Type PROCEDURE

Telescopic overdenture with two dental implants in intraforaminal area for mandible.

3D printed chrom cobalt copings.

Group Type EXPERIMENTAL

Telescopic overdenture

Intervention Type PROCEDURE

Telescopic overdenture with two dental implants in intraforaminal area for mandible.

Milled Poly-ether Ketone Ketones copings.

Group Type EXPERIMENTAL

Telescopic overdenture

Intervention Type PROCEDURE

Telescopic overdenture with two dental implants in intraforaminal area for mandible.

Interventions

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Telescopic overdenture

Telescopic overdenture with two dental implants in intraforaminal area for mandible.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Sufficient remaining bone in height, width and thickness in the interforaminal area to allow installation of at least 3.3 mm diameter and 8 mm length implants.
2. Adequate amount of interarch space of at least 12mm.
3. Age range from 55 to 75 years old age.

Exclusion Criteria

1. Systemic and metabolic diseases that may affect osseointegration.
2. Patients receiving bisphosphonates therapy.
3. Patients under radiotherapy or chemotherapy.
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Moustafa mohamed el maghraby

Assistant lecturer of prosthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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EL Minia University

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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613

Identifier Type: OTHER

Identifier Source: secondary_id

Randomized clinical trial

Identifier Type: -

Identifier Source: org_study_id

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