Vertical Alveolar Bone LossNCT06640127
Use of Specifically Designed Drills for Internal Sinus Lifting
A study testing Sinus lifting and implant placement with osteotomes and Sinus lifting and implant placement with specifically designed drills in people with Vertical Alveolar Bone Loss and Sinus Lifting, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted at Ege University, School of Dentistry, Izmir, Turkey. Patients enrolled require implant placement to the atrophic posterior maxilla. Patients were treated with either the specifically designed drills or the osteotomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vertical Alveolar Bone Loss, Sinus Lifting, Implant Therapy
- What is being tested?
- Sinus lifting and implant placement with osteotomes and Sinus lifting and implant placement with specifically designed drills
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2022to 22 Jan 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Unilaterally or bilaterally missing teeth in the posterior maxilla,
- Residual bone height (4 mm to 6 mm),
- Completed periodontal and oral hygiene treatment,
- American Society of Anesthesiologists (ASA) score of I or II,
- > 18 years old,
- Willingness to participate
Who cannot join
- Infection or pathology related to maxillary sinus and surgical site,
- Tooth extraction within six months in the surgical site,
- Previous maxillary sinus surgery,
- Parafunction,
- Medical conditions associated with impaired or delayed wound healing,
- Smoking habit and alcohol or drug abuse,
- Pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Dentistry
Izmir, Bornova, 35100
About this study
Official title: A Randomized Comparative Study on Internal Sinus Lifting With Simultaneous Implant Placement Using Two Different Techniques
This study was conducted at Ege University, School of Dentistry, Izmir, Turkey. Patients enrolled require implant placement to the atrophic posterior maxilla. Patients were treated with either the specifically designed drills or the osteotomes. The outcome variables were primary stability, marginal bone loss, implant survival, and patient-reported outcomes. The investigators aimed to compare the treatment outcomes of two different techniques used in dental implant placement with internal sinus lifting.
Read the detailed description
This prospective, randomized clinical study was conducted at the Ege University School of Dentistry and Department of Oral and Maxillofacial Surgery. Patients with atrophic maxillas and at least one tooth loss in this region were included. Randomization was performed to assign the patients to study groups. Patients treated with internal sinus lift using osteotome and implant surgery were assigned to Group 1, and patients treated with internal sinus lift using specifically designed drills and implant surgery were assigned to Group 2. At six months postoperatively, the healing cap was inserted during the second stage of surgery.
All implants were assessed based on primary stability (using implant stability quotient and torque value), marginal bone loss (as millimeters), and implant survival (as a percentage). Also, patient-reported outcomes were collected, including pain (using a visual analog scale), analgesic consumption (number of drugs taken during a week), and oral health impact profile survey).
- Conditions
- Vertical Alveolar Bone Loss, Sinus Lifting, Implant Therapy
- Being tested
- Sinus lifting and implant placement with osteotomes, Sinus lifting and implant placement with specifically designed drills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus lifting and implant placement with osteotomesProcedure or surgery
Osteotomes with increasing diameters were used for sinus membrane elevation and implant insertion
Sinus lifting and implant placement with specifically designed drillsProcedure or surgery
Sequential drills were used for sinus membrane elevation and implant insertion
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Sinus lifting and implant placement with osteotomes Receives: Procedure: Sinus lifting and implant placement with osteotomes |
| Test Group | Experimental | Sinus lifting and implant placement with specifically designed drills Receives: Procedure: Sinus lifting and implant placement with specifically designed drills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of implant insertion quantity (ISQ) value
Calculation of ISQ value for each implant
Measured: at surgery
Mean of torque value
Calculation of torque value for each implant
Measured: at surgery
Secondary outcomes (5)
Marginal bone loss
Change in peri-implant bone level
Measured: through study completion, an average of 1 year
Implant survival
Number of mobil or loss implants
Measured: through study completion, an average of 1 year
Pain Score
Pain level recorded between 0 to 10 points
Measured: at postoperative first week
Analgesic consumption
Number of analgesic taken on a daily basis
Measured: at postoperative first week
Oral health impact profile questionnaire
Total score of self-administered questionnaire assessed using Likert-point scale between 0 to 4
Measured: preoperatively, at postoperative first week, and at postoperative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start3 Jan 2022
- Primary completion17 Oct 2023
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertical Alveolar Bone LossStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Işık, Ege University
- Investigators
- Gözde Işık, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640127
- Sponsor's protocol ID
- 22-4.1/30
- Other IDs
- 23834
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Study on Internal Sinus Lifting With Simultaneous Implant Placement Using Two Different Techniques
- ClinicalTrials.gov ID
- NCT06640127
- Acronym / sponsor ID
- 22-4.1/30
- Conditions
- Vertical Alveolar Bone Loss, Sinus Lifting, Implant Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 15 Oct 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.
This study was conducted at Ege University, School of Dentistry, Izmir, Turkey. Patients enrolled require implant placement to the atrophic posterior maxilla. Patients were treated with either the specifically designed drills or the osteotomes. The outcome variables were primary stability, marginal bone loss, implant survival, and patient-reported outcomes. The investigators aimed to compare the treatment outcomes of two different techniques used in dental implant placement with internal sinus lifting.
Detailed description
This prospective, randomized clinical study was conducted at the Ege University School of Dentistry and Department of Oral and Maxillofacial Surgery. Patients with atrophic maxillas and at least one tooth loss in this region were included. Randomization was performed to assign the patients to study groups. Patients treated with internal sinus lift using osteotome and implant surgery were assigned to Group 1, and patients treated with internal sinus lift using specifically designed drills and implant surgery were assigned to Group 2. At six months postoperatively, the healing cap was inserted during the second stage of surgery.
All implants were assessed based on primary stability (using implant stability quotient and torque value), marginal bone loss (as millimeters), and implant survival (as a percentage). Also, patient-reported outcomes were collected, including pain (using a visual analog scale), analgesic consumption (number of drugs taken during a week), and oral health impact profile survey).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Sinus lifting and implant placement with osteotomesSinus lifting and implant placement with osteotomes |
| Test Group | Experimental | Procedure: Sinus lifting and implant placement with specifically designed drillsSinus lifting and implant placement with specifically designed drills |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilaterally or bilaterally missing teeth in the posterior maxilla,
- Residual bone height (4 mm to 6 mm),
- Completed periodontal and oral hygiene treatment,
- American Society of Anesthesiologists (ASA) score of I or II,
- > 18 years old,
Key exclusion criteria (7 listed)
- Infection or pathology related to maxillary sinus and surgical site,
- Tooth extraction within six months in the surgical site,
- Previous maxillary sinus surgery,
- Parafunction,
- Medical conditions associated with impaired or delayed wound healing,
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 |
|---|---|---|
| Sinus lifting and implant placement with osteotomesOsteotomes with increasing diameters were used for sinus membrane elevation and implant insertion | Procedure or surgery | Control Group |
| Sinus lifting and implant placement with specifically designed drillsSequential drills were used for sinus membrane elevation and implant insertion | Procedure or surgery | Test Group |
Primary outcome
Mean of implant insertion quantity (ISQ) value
Time frame: at surgery
Calculation of ISQ value for each implant
Mean of torque value
Time frame: at surgery
Calculation of torque value for each implant
5 secondary outcomes
Marginal bone loss
Time frame: through study completion, an average of 1 year
Implant survival
Time frame: through study completion, an average of 1 year
Pain Score
Time frame: at postoperative first week
Analgesic consumption
Time frame: at postoperative first week
Oral health impact profile questionnaire
Time frame: preoperatively, at postoperative first week, and at postoperative 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Vertical Alveolar Bone Loss
Active, not recruiting
Simultaneous Implant Placement With Vertical and Horizontal Bone Augmentation
Alveolar Bone Loss, Dental Implant Failed
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Novel Synthetic Membrane for Horizontal Bone Augmentation: A Case Series
Alveolar Ridge Deficiency, Alveolar Bone Loss
RecruitingObservational study
Digital Planning and Clinical Assessment of the Treated Atrophic Posterior Maxilla With a Sinus Lift Procedure: a Cross-sectional Study.
Alveolar Bone Atrophy, Alveolar Bone Grafting
RecruitingObservational study
The Role of Granulation Tissue in Periodontal Regeneration
Periodontal Bone Loss, Periodontitis
Not yet recruiting
Radiographic and Histomorphometric Assessment for Alveolar Ridge Preservation Using Autogenous Tooth Graft From Extracted Tooth Combined With Simvastatin 1:1 Versus Autogenous Tooth Graft
Alveolar Ridge Preservation, Horizontal Alveolar Bone Loss
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.
Gözde Işık principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinus lifting and implant placement with osteotomes and Sinus lifting and implant placement with specifically designed drills in people with Vertical Alveolar Bone Loss and Sinus Lifting, run by Ege University at 1 site in Turkey (Türkiye).
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean of implant insertion quantity (ISQ) value (time frame: at surgery). 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 15 Oct 2024.