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Completed

NCT Number: NCT05125445

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

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

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Key information

Conditions

Dental Implant Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implants placed at bone crest

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

Implants placed 1mm Subcrestally

Procedure

Implants will be placed 1mm subcrestally

Primary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2021
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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