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

NCT05125445 | Completed

• 1 other identifier: Implants_diabetes
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Implant; Diabetes

Outcome Measures

Primary Outcomes (2)

• change in Implant stability

  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

  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

Study Arms (2)

Crestally positioned implants

EXPERIMENTAL

Procedure: Implants placed at bone crest

Subcrestally positioned implants

ACTIVE COMPARATOR

Procedure: Implants placed 1mm Subcrestally

Interventions

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

Crestally positioned implants

Implants placed 1mm Subcrestally PROCEDURE

Implants will be placed 1mm subcrestally

Subcrestally positioned implants

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

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

Alexandria, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: November 7, 2021
• First Posted: November 18, 2021
• Study Start: February 11, 2021
• Primary Completion: August 23, 2021
• Study Completion: August 23, 2021
• Last Updated: November 18, 2021

Record last verified: 2021-11

Locations

EG (1)