Dental Implant Surgical TechniquesNCT06243276
Effect of Diabetes on Short İmplants in One- and Two-Stage Surgeries
A study testing One stage implant surgery and Two stage implant surgery in people with Dental Implant Surgical Techniques and Diabetes Mellitus, run by Erzincan University.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Surgical Techniques, Diabetes Mellitus, Short Dental Implants
- What is being tested?
- One stage implant surgery and Two stage implant surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2024to 14 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Effects of Diabetes on Two Short Implants Splinted Using One- and Two-stage Techniques: Split-mouth Study With One-year Follow-up.
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?
Read more
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.
- Being tested
- One stage implant surgery, Two stage implant surgery
- Keywords
- Dental Implants, Short Dental Implants, One Stage Implant Surgery, Two Stage Implant Surgery, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One stage implant surgeryProcedure or surgery
It is a technique in which the healing cap is connected to the implant at the stage of implant placement.
Two stage implant surgeryProcedure or surgery
It is a technique in which the healing cap is connected to the implant three months after the implant is placed.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Active comparator | Not described Receives: Procedure: One stage implant surgery; Procedure: Two stage implant surgery |
| Healthy patient | Active comparator | Not described Receives: Procedure: One stage implant surgery; Procedure: Two stage implant surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of 12 months of follow-up from the surgery in which the implant was placed in the bone
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.
Measured: Three months after the implant is placed in the bone. (At the end of three months)
Secondary outcomes (2)
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start5 Jun 2024 (estimated)
- Primary completion14 Jun 2024 (estimated)
- Study completion14 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant Surgical TechniquesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Split-mouth study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Collaborators
- Mode Medical Implant Manufacturer
- Responsible party
- Principal investigator, Ömer Faruk Okumuş, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243276
- Sponsor's protocol ID
- EUDF-OKUMUS-002
- Status last verified
- May 2024
- First submitted
- 18 Jan 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diabetes on Two Short Implants Splinted Using One- and Two-stage Techniques: Split-mouth Study With One-year Follow-up.
- ClinicalTrials.gov ID
- NCT06243276
- Acronym / sponsor ID
- EUDF-OKUMUS-002
- Keywords
- Dental Implants, Short Dental Implants, One Stage Implant Surgery, Two Stage Implant Surgery, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Collaborators
- Mode Medical Implant Manufacturer
- Study start
- 5 Jun 2024 (estimated)
- Primary completion
- 14 Jun 2024 (estimated)
- Study completion
- 14 May 2025 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth study
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | Active comparator | Procedure: One stage implant surgery, Procedure: Two stage implant surgery |
| Healthy patient | Active comparator | Procedure: One stage implant surgery, Procedure: Two stage implant surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One stage implant surgeryIt is a technique in which the healing cap is connected to the implant at the stage of implant placement. | Procedure or surgery | Diabetic patients, Healthy patient |
| Two stage implant surgeryIt is a technique in which the healing cap is connected to the implant three months after the implant is placed. | Procedure or surgery | Diabetic patients, Healthy patient |
Primary outcome
One-year survival of the implant
Time frame: At the end of 12 months of follow-up from the surgery in which the implant was placed in the bone
To observe whether the implant is performing its function. The implant continues to support the tooth connected to it.
Evaluation of the status of osseointegration
Time frame: Three months after the implant is placed in the bone. (At the end of three months)
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.
2 secondary outcomes
Implant Stability Quotient (ISQ Value)
Time frame: 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
Marginal bone level change
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing One stage implant surgery and Two stage implant surgery in people with Dental Implant Surgical Techniques and Diabetes Mellitus, run by Erzincan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year survival of the implant (time frame: At the end of 12 months of follow-up from the surgery in which the implant was placed in the bone). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.