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

Diabetes Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05125445
• Other study ID #: Implants_diabetes
• Status: Completed
• Phase: N/A
• Start date: February 11, 2021
• Est. completion date: August 23, 2021

Study information

• Verified date: November 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 23, 2021
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implant
• Diabetes

Intervention

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
• Implants placed 1mm Subcrestally
Implants will be placed 1mm subcrestally

Locations

Country	Name	City	State
Egypt	Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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