Clinical trial NCT06243276: Effect of Diabetes on Short İmplants in One- and Two-Stage Surgeries
Official title: Effects of Diabetes on Two Short Implants Splinted Using One- and Two-stage Techniques: Split-mouth Study With One-year Follow-up.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Implant Surgical Techniques
Diabetes Mellitus
Short Dental Implants
Keywords: Dental Implants
Short Dental Implants
One Stage Implant Surgery
Two Stage Implant Surgery
Diabetes Mellitus
Lead sponsor: Erzincan University
Sponsor class: OTHER
Collaborators: name: Mode Medical Implant Manufacturer
First posted: 2024-02-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Split-mouth study
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: One-year survival of the implant
timeFrame: At the end of 12 months of follow-up from the surgery in which the implant was placed in the bone
measure: Evaluation of the status of osseointegration
timeFrame: Three months after the implant is placed in the bone. (At the end of three months)
Secondary outcomes:
measure: Implant Stability Quotient (ISQ Value)
timeFrame: 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
measure: Marginal bone level change
timeFrame: 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
Other outcomes:
Locations:
Study officials:
References: