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

NCT ID: NCT06243276

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-05

Study Completion Date

2025-05-14

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Implant Surgical Techniques Diabetes Mellitus Short Dental Implants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Split-mouth study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Diabetic patients

Group Type ACTIVE_COMPARATOR

One stage implant surgery

Intervention Type PROCEDURE

It is a technique in which the healing cap is connected to the implant at the stage of implant placement.

Two stage implant surgery

Intervention Type PROCEDURE

It is a technique in which the healing cap is connected to the implant three months after the implant is placed.

Healthy patient

Group Type ACTIVE_COMPARATOR

One stage implant surgery

Intervention Type PROCEDURE

It is a technique in which the healing cap is connected to the implant at the stage of implant placement.

Two stage implant surgery

Intervention Type PROCEDURE

It is a technique in which the healing cap is connected to the implant three months after the implant is placed.

Interventions

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One stage implant surgery

It is a technique in which the healing cap is connected to the implant at the stage of implant placement.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mode Medical Implant Manufacturer

UNKNOWN

Sponsor Role collaborator

Erzincan University

OTHER

Sponsor Role lead

Responsible Party

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Ömer Faruk Okumuş

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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EUDF-OKUMUS-002

Identifier Type: -

Identifier Source: org_study_id

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