Effect of Diabetes on Short İmplants in One- and Two-Stage Surgeries
NCT ID: NCT06243276
Last Updated: 2024-05-28
Study Results
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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NOT_YET_RECRUITING
NA
32 participants
INTERVENTIONAL
2024-06-05
2025-05-14
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Diabetic patients
One stage implant surgery
It is a technique in which the healing cap is connected to the implant at the stage of implant placement.
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.
Healthy patient
One stage implant surgery
It is a technique in which the healing cap is connected to the implant at the stage of implant placement.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Mode Medical Implant Manufacturer
UNKNOWN
Erzincan University
OTHER
Responsible Party
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Ömer Faruk Okumuş
Assistant Professor
Other Identifiers
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EUDF-OKUMUS-002
Identifier Type: -
Identifier Source: org_study_id
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