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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06243276
• Other study ID #: EUDF-OKUMUS-002
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 5, 2024
• Est. completion date: May 14, 2025

Study information

• Verified date: May 2024
• Source: Erzincan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: May 14, 2025
• Est. primary completion date: June 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Erzincan University	Mode Medical Implant Manufacturer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One-year survival of the implant	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
Primary	Evaluation of the status of osseointegration	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	Implant Stability Quotient (ISQ Value)	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
Secondary	Marginal bone level change	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