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

November 7, 2021 updated by: Hams Hamed Abdelrahman

Evaluation of Stability and Crestal Bone Changes Around Implants Placed at Crestal Versus Subcrestal Level in Controlled Type Two Diabetic Patients (Randomized Clinical Trial)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Crestally positioned implants
Procedure: 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
Active Comparator: Subcrestally positioned implants
Procedure: Implants placed 1mm Subcrestally
Implants will be placed 1mm subcrestally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Implant stability
Time Frame: at baseline and 3 months
Implant stability will be measured again by Osstell at 3 different directions (buccal, mesial and distal) at the time of implant loading (after 3 months from implant placement).
at baseline and 3 months
change in margianl bone level
Time Frame: at baseline, 3rd and 6th months
CBCT will be done Marginal bone loss in all aspects (mesial, distal buccal and lingual) The difference in distance from bone crest to apical end of the implant will be assessed at each follow up period then the mean will be calculated for mesial and distal and also for buccal and lingual.
at baseline, 3rd and 6th months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hams Hamed Abdelrahman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2021

Primary Completion (Actual)

August 23, 2021

Study Completion (Actual)

August 23, 2021

Study Registration Dates

First Submitted

November 7, 2021

First Submitted That Met QC Criteria

November 7, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Actual)

November 18, 2021

Last Update Submitted That Met QC Criteria

November 7, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Implants_diabetes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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