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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05125445

Enrollment

Registered

2021-11-18

Start date

2021-02-11

Completion date

2021-08-23

Last updated

2021-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant, Diabetes

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

Interventions

PROCEDUREImplants 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

PROCEDUREImplants placed 1mm Subcrestally

Implants will be placed 1mm subcrestally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
change in Implant stability	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).
change in margianl bone level	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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026