Effect of Diabetes on Short İmplants in One- and Two-Stage Surgeries

February 5, 2024 updated by: Ömer Faruk Okumuş, Erzincan University

Effects of Diabetes on Two Short Implants Splinted Using One- and Two-stage Techniques: Split-mouth Study With One-year Follow-up.

The goal of this clinical trial is to compare one- and two-stage techniques for short implant surgery in diabetes. The main questions it aims to answer are:

  • Is one-stage short implant surgery at risk of implant osseointegration in diabetic patients compared to two-stage surgery?
  • Is one-stage short implant surgery associated with a risk of implant survival (at one-year follow-up) in diabetic patients compared to two-stage surgery?
  • What are the effects of one- and two-stage short implant surgery on the marginal bone loss or ISQ (implant stability coefficient - resonance frequency analysis device measurement) values of the implant in diabetic patients?

Participants will come for their 3rd, 6th and 12th month controls.

  • Participants will receive two adjacent short implants.
  • A randomly selected one of these short implants will undergo a one-stage implant surgery, and the other a two-stage implant surgery.
  • Data will be obtained through non-invasive evaluation methods during the surgery and subsequent control stages.

Researchers will also test one- and two-stage short implant surgeries in a control group of healthy individuals. Thus, the effects of diabetes on these two techniques will be better understood by comparing them with the healthy control group.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The maxillary and mandibular posterior region (distal part of the canine in each quadrant) must have toothless space for two adjacent short implants.
  • The edentulous space must have a vertical bone height of at least 5 mm. (Distance to maxillary sinus and alveolar nerve)
  • The edentulous space should not require horizontal bone augmentation. (for implants with diameters 3.7 - 4.1 - 4.7 - 5.3)
  • Bleeding on probing should be less than 10%. There should be no pathological pockets in any tooth.
  • Participant should not smoke more than 10 cigarettes per day.
  • More than 6 months must have passed since the tooth extraction from the edentulous area.
  • Should not have bruxism
  • If it is diabetes, the HbA1c value should be greater than 6.5, and if it is healthy control, the HbA1c value should be between 4 and 5.

Exclusion Criteria:

  • Having psychological problems
  • Smoking more than 10 cigarettes per day
  • Pregnancy status if female patient
  • Having a medication or disease that will cause abnormal post-operative bleeding
  • Alcohol and drug use

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diabetic patients
Procedure: One stage implant surgery
It is a technique in which the healing cap is connected to the implant at the stage of implant placement.
Procedure: Two stage implant surgery
It is a technique in which the healing cap is connected to the implant three months after the implant is placed.
Active Comparator: Healthy patient
Procedure: One stage implant surgery
It is a technique in which the healing cap is connected to the implant at the stage of implant placement.
Procedure: Two stage implant surgery
It is a technique in which the healing cap is connected to the implant three months after the implant is placed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One-year survival of the implant
Time Frame: At the end of 12 months of follow-up from the surgery in which the implant was placed in the bone
To observe whether the implant is performing its function. The implant continues to support the tooth connected to it.
At the end of 12 months of follow-up from the surgery in which the implant was placed in the bone
Evaluation of the status of osseointegration
Time Frame: Three months after the implant is placed in the bone. (At the end of three months)
Fusion of the dental implant with the bone at the microscopic level. Osseointegration will be evaluated as successful or unsuccessful. Successful osseointegration is defined by no mobility in the implant, no radiolucency around the implant on radiography, and no pain in the implant. Otherwise, the osseointegration of the implant is considered unsuccessful.
Three months after the implant is placed in the bone. (At the end of three months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Stability Quotient (ISQ Value)
Time Frame: 1- Surgical stage where the implant is placed; 2- Three months after the implant is placed in the bone. At the end of three months
The value obtained by the resonance frequency analysis (RFA) device used to measure the primary stability of dental implants. The RFA technique is based on continual excitation of the implant through dynamic vibration analysis. A transducer is connected to an implant, which is excited over a range of sound frequencies with subsequent measurement of the vibratory oscillation of the implant. It is a non-invasive technique.
1- Surgical stage where the implant is placed; 2- Three months after the implant is placed in the bone. At the end of three months
Marginal bone level change
Time Frame: 1- Surgical stage where the implant is placed; 2- Three months after the implant is placed in the bone; 3- Six months after the implant is placed in the bone; 4- Twelve months after the implant is placed in the bone
It defines the change in the marginal bone level in the neck area of the implant. It is determined by radiographic examination. The initial radiograph is compared with the radiograph at the end of three months. In measurements where the implant platform is the reference point, bone level changes are calculated in mm.
1- Surgical stage where the implant is placed; 2- Three months after the implant is placed in the bone; 3- Six months after the implant is placed in the bone; 4- Twelve months after the implant is placed in the bone

Collaborators and Investigators

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

Sponsor

Erzincan University

Collaborators

Mode Medical Implant Manufacturer

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 (Estimated)

March 15, 2024

Primary Completion (Estimated)

June 14, 2024

Study Completion (Estimated)

May 14, 2025

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

January 28, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUDF-OKUMUS-002

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.

Clinical Trials on Diabetes Mellitus

Clinical Trials on One stage implant surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe