Stability and Crestal Bone Changes Around Implants Placed at Crestal Versus Subcrestal Level in Controlled Type Two Diabetic Patients

NCT ID: NCT05125445

Last Updated: 2021-11-18

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

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-11

Study Completion Date

2021-08-23

Brief Summary

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The objective of this study is to assess clinically the peri implant tissues, the radiological marginal bone loss and the stability around implants placed at the crestal versus the subcrestal level in type 2 controlled diabetic patients using cone beam computed tomography

Detailed Description

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Conditions

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Dental Implant Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Crestally positioned implants

Group Type EXPERIMENTAL

Implants placed at bone crest

Intervention Type PROCEDURE

Mid crestal incision will be performed and full-thickness envelope flap will be elevated to expose the alveolar ridge (no releasing incisions will be made).

Implant site will be prepared according to the manufacturer's instructions under sterile copious irrigation Implants will be placed at crestal level

Subcrestally positioned implants

Group Type ACTIVE_COMPARATOR

Implants placed 1mm Subcrestally

Intervention Type PROCEDURE

Implants will be placed 1mm subcrestally

Interventions

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Implants placed at bone crest

Mid crestal incision will be performed and full-thickness envelope flap will be elevated to expose the alveolar ridge (no releasing incisions will be made).

Implant site will be prepared according to the manufacturer's instructions under sterile copious irrigation Implants will be placed at crestal level

Intervention Type PROCEDURE

Implants placed 1mm Subcrestally

Implants will be placed 1mm subcrestally

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Type 2 controlled diabetic patients
* Patients with at least one missing tooth in lower jaw.
* Patients with sufficient alveolar ridge height and width (no need for bone augmentation).
* Patients with sufficient inter-occlusal distance that will allow future restoration.
* Patients with healthy periodontium.

Exclusion Criteria

* Smokers.
* Para functional habits.
* Bad oral hygiene measured according to O'Leary plaque index.
* Pregnant women.
* Other local or systemic diseases that may compromise the surgical procedure, healing or osteointegration.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

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Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Implants_diabetes

Identifier Type: -

Identifier Source: org_study_id