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

E

Erzincan University

Status

Not yet enrolling

Conditions

Dental Implant Surgical Techniques
Short Dental Implants
Diabetes Mellitus

Treatments

Procedure: One stage implant surgery
Procedure: Two stage implant surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT06243276
EUDF-OKUMUS-002

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

32 participants in 2 patient groups

Diabetic patients
Active Comparator group
Treatment:
Procedure: Two stage implant surgery
Procedure: One stage implant surgery
Healthy patient
Active Comparator group
Treatment:
Procedure: Two stage implant surgery
Procedure: One stage implant surgery

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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