Dental ImplantationNCT07052747
Periodontal Effects of Orthodontic Mini-Screws
An observational study of Dental Implantation and Peri-implant Mucositis, run by Dr. Mehmet Selim Yildiz at 1 site in Turkey (Türkiye).
Trial summary
Orthodontic mini-screws (TADs) are commonly used to provide temporary anchorage and prevent unwanted tooth movement during orthodontic treatment. Their clinical success largely depends on their ability to remain stable under functional orthodontic loads. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Implantation, Peri-implant Mucositis, Orthodontic Anchorage Procedures
- What is being tested?
- Clinical periodontal assessment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Oct 2024to 29 Apr 2025
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study included patients who had been treated with orthodontic mini implants at the Department of Orthodontics, Faculty of Dentistry, Altinbas University. A total of 132 patients were included in the study.
Who may be able to join
- Systemically healthy individuals; non-smokers; patients undergoing fixed orthodontic treatment requiring mini-screw anchorage; periodontally healthy (bleeding on probing <10%); no clinical signs of gingival inflammation at the time of mini-screw placement; provided written informed consent.
Who cannot join
- History of systemic disease (e.g., diabetes, immunosuppression); current use of antibiotics, corticosteroids, or other medications affecting periodontal health; history of radiation therapy in the head and neck region; poor oral hygiene or visible plaque accumulation at baseline; pregnant or breastfeeding women; presence of active periodontal disease (e.g., PPD >3 mm, BOP >10%); previous orthodontic mini-screw failure in the same site.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Altinbas University, Faculty of Dentistry
Istanbul, Bakırköy, 34147
About this study
Official title: Periodontal Health and Orthodontic Mini-screws: A Cross-sectional Study
Orthodontic mini-screws (TADs) are commonly used to provide temporary anchorage and prevent unwanted tooth movement during orthodontic treatment. Their clinical success largely depends on their ability to remain stable under functional orthodontic loads. Stability is assessed in two phases: primary stability, which reflects immediate mechanical retention in bone, and secondary stability, which results from biological remodeling and healing over time. Multiple factors such as age, gender, bone characteristics, screw dimensions, and force magnitude may influence screw stability.
Recent studies suggest that local inflammation around mini-screws, similar to peri-implantitis in dental implants, can compromise bone integrity and lead to screw failure. Inadequate oral hygiene and the absence of keratinized tissue at the insertion site are among the key risk factors associated with inflammation and soft tissue complications. Unlike traditional implants, mini-screws are often inserted at variable intraoral locations and subject to angular force vectors, which may further impact surrounding periodontal tissues.
This cross-sectional clinical study aims to evaluate the effects of orthodontic mini-screw placement on general oral health and periodontal tissue status. The study will investigate site-specific and full-mouth periodontal parameters and explore potential associations between mini-screw stability, soft tissue characteristics, and signs of mucosal inflammation.
Read the detailed description
Orthodontic mini-screws, also known as temporary anchorage devices (TADs), have become an integral component of modern orthodontic therapy, enabling controlled tooth movement without relying on patient compliance. For optimal clinical success, these devices must maintain mechanical stability throughout the treatment period. Stability is commonly categorized into two types: primary stability, which represents the initial mechanical engagement of the screw with cortical bone, and secondary stability, which depends on bone remodeling and healing processes occurring over time.
Despite their clinical utility, mini-screws are prone to several biological and mechanical challenges that may compromise their stability. Factors such as patient age, gender, cortical bone thickness, screw dimensions, insertion torque, and the magnitude and direction of orthodontic forces are known to affect outcomes. Moreover, local inflammatory responses-particularly in the presence of poor oral hygiene or non-keratinized soft tissue-can lead to tissue breakdown and mini-screw failure. These inflammatory reactions resemble peri-implantitis observed in dental implants and are thought to result in marginal bone loss, especially around the neck of the mini-screw.
Given the biomechanical complexity and variability in intraoral placement, orthodontic mini-screws may provoke localized periodontal changes, even in periodontally healthy individuals. However, limited data are available on how these devices influence surrounding periodontal tissues at both the site level and full-mouth level, particularly during the early healing phase after placement.
This cross-sectional clinical study aims to evaluate the relationship between orthodontic mini-screws and periodontal health three months after screw placement. A total of 132 systemically healthy, non-smoking patients with 160 mini-screw insertions will be included. Clinical parameters such as plaque index (PI), gingival index (GI), probing pocket depth (PPD), recession depth (RD), bleeding on probing (BOP), keratinized tissue width (KTW), supracrestal tissue height (STH), transmucosal soft tissue thickness (phenotype), mucosal redness (MR), and mucosal discomfort (MD) will be measured both site-specifically and at the full-mouth level. In addition, torque gauge (TG) measurements will be used to assess mechanical stability of the mini-screws.
The study aims to identify whether site-specific inflammation and soft tissue characteristics correlate with decreased implant stability or patient-reported discomfort. Results may provide valuable insights into the biological response of periodontal tissues to TADs and help improve clinical protocols for their placement, monitoring, and maintenance.
- Conditions
- Dental Implantation, Peri-implant Mucositis, Orthodontic Anchorage Procedures, Gingival Inflammation and Bleeding
- Being tested
- Clinical periodontal assessment
- Medical subject headings
- Gingivitis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical periodontal assessmentOther
Comprehensive site-level and full-mouth evaluations of periodontal parameters, including plaque index (PI), gingival index (GI), probing pocket depth (PPD), recession depth (RD), bleeding on probing (BOP), keratinized tissue width (KTW), mucosal phenotype, mucosal redness (MR), mucosal discomfort (MD), and torque gauge (TG) measurements.
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket Depth (PPD)
Mean PPD measured at six sites around each of the two teeth adjacent to the mini-screw, using a UNC-15 periodontal probe. Values are averaged per site to assess localized periodontal response. This measurement also done for full-mouth teeth.
Measured: 3 months after mini-screw placement
Plaque Index (PI)
Plaque accumulation assessed visually on the buccal and lingual surfaces of teeth adjacent to the mini-screw and for full-mouth teeth using the Löe and Silness Index. Values averaged across sites.
Measured: 3 months after mini-screw placement
Gingival Index (GI)
Gingival inflammation assessed using the Löe and Silness Gingival Index at the six surfaces of the adjacent teeth and full mouth seperately. Scores averaged to evaluate site-specific soft tissue response.
Measured: 3 months after mini-screw placement
Bleeding on Probing (BOP)
Presence or absence of bleeding recorded at six sites per adjacent tooth and full mouth teeth immediately after gentle probing. The percentage of bleeding sites is calculated to assess inflammation.
Measured: 3 months after mini-screw placement
Gingival Recession Depth (RD)
Distance from the cemento-enamel junction to the free gingival margin measured at six sites of adjacent teeth. Mean values indicate apical migration of the gingiva.
Measured: 3 months after mini-screw placement
Mucosal Redness (MR)
Clinical assessment of redness in the mucosa surrounding the mini-screw, based on visual inspection. Recorded as present or absent.
Measured: 3 months after mini-screw placement
Mucosal Discomfort (MD)
Self-reported discomfort or sensitivity around the mini-screw site, recorded during the clinical examination. Binary outcome (present or absent).
Measured: 3 months after mini-screw placement
Keratinized Tissue Width (KTW)
Horizontal and vertical keratinized tissue widths measured using a periodontal probe in millimeters. Recorded to evaluate soft tissue protection at the site.
Measured: 3 months after mini-screw placement
Supracrestal Tissue Height (STH)
Vertical height from the alveolar crest to the gingival margin measured at the mini-screw site using a periodontal probe. Indicates soft tissue volume and attachment.
Measured: 3 months after mini-screw placement
Transmucosal Soft Tissue Thickness (Phenotype)
Measured using a periodontal probe to determine whether the phenotype is thick or thin. Helps assess how mucosal type influences peri-screw tissue response.
Measured: 3 months after mini-screw placement
Torque Gauge (TG) Value
Stability of each mini-screw measured using a torque gauge. Values recorded in Newtons to assess biomechanical resistance of the screw at 3-month follow-up.
Measured: 3 months after mini-screw placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2025
- Study start4 Oct 2024
- Primary completion25 Apr 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Mehmet Selim Yildiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Mehmet Selim Yildiz, Altinbas University
- Investigators
- Mehmet Selim YILDIZ, Asst. Prof., Principal investigator, Altinbas University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052747
- Sponsor's protocol ID
- 2024/30
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 7 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers can request access to the IPD by contacting Dr. Mehmet Selim Yildiz at "mehmet.yildiz2@altinbas.edu.tr or mehmetselimyildiz4@gmail.com"
Publications
Yildiz MS, Ulutas PA, Ozenci I, Akcali A. Clinical and radiographic assessment of the association between orthodontic mini-screws and periodontal health. BMC Oral Health. 2024 Nov 14;24(1):1376. doi: 10.1186/s12903-024-05136-2.
PubMed 39543578Parmar R, Reddy V, Reddy SK, Reddy D. Determination of soft tissue thickness at orthodontic miniscrew placement sites using ultrasonography for customizing screw selection. Am J Orthod Dentofacial Orthop. 2016 Oct;150(4):651-658. doi: 10.1016/j.ajodo.2016.03.026.
PubMed 27692423Park HS, Jeong SH, Kwon OW. Factors affecting the clinical success of screw implants used as orthodontic anchorage. Am J Orthod Dentofacial Orthop. 2006 Jul;130(1):18-25. doi: 10.1016/j.ajodo.2004.11.032.
PubMed 16849067Zitzmann NU, Berglundh T, Ericsson I, Lindhe J. Spontaneous progression of experimentally induced periimplantitis. J Clin Periodontol. 2004 Oct;31(10):845-9. doi: 10.1111/j.1600-051X.2004.00567.x.
PubMed 15367187Algraffee H, Borumandi F, Cascarini L. Peri-implantitis. Br J Oral Maxillofac Surg. 2012 Dec;50(8):689-94. doi: 10.1016/j.bjoms.2011.11.020. Epub 2011 Dec 22.
PubMed 22197573Lee SJ, Ahn SJ, Lee JW, Kim SH, Kim TW. Survival analysis of orthodontic mini-implants. Am J Orthod Dentofacial Orthop. 2010 Feb;137(2):194-9. doi: 10.1016/j.ajodo.2008.03.031.
PubMed 20152674Ure DS, Oliver DR, Kim KB, Melo AC, Buschang PH. Stability changes of miniscrew implants over time. Angle Orthod. 2011 Nov;81(6):994-1000. doi: 10.2319/120810-711.1. Epub 2011 May 25.
PubMed 21612317Raghavendra S, Wood MC, Taylor TD. Early wound healing around endosseous implants: a review of the literature. Int J Oral Maxillofac Implants. 2005 May-Jun;20(3):425-31.
PubMed 15973954Yildiz MS, Ulutas PA, Akcali A. Periodontal health and orthodontic mini-screws: a cross-sectional study. J Periodontal Implant Sci. 2026 Mar 23. doi: 10.5051/jpis.2503060153. Online ahead of print.
PubMed 41968715
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Health and Orthodontic Mini-screws: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07052747
- Acronym / sponsor ID
- 2024/30
- Conditions
- Dental Implantation, Peri-implant Mucositis, Orthodontic Anchorage Procedures, Gingival Inflammation and Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Dr. Mehmet Selim YildizUniversity, hospital or other
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 7 Jul 2025 (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.
Orthodontic mini-screws (TADs) are commonly used to provide temporary anchorage and prevent unwanted tooth movement during orthodontic treatment. Their clinical success largely depends on their ability to remain stable under functional orthodontic loads. Stability is assessed in two phases: primary stability, which reflects immediate mechanical retention in bone, and secondary stability, which results from biological remodeling and healing over time. Multiple factors such as age, gender, bone characteristics, screw dimensions, and force magnitude may influence screw stability.
Recent studies suggest that local inflammation around mini-screws, similar to peri-implantitis in dental implants, can compromise bone integrity and lead to screw failure. Inadequate oral hygiene and the absence of keratinized tissue at the insertion site are among the key risk factors associated with inflammation and soft tissue complications. Unlike traditional implants, mini-screws are often inserted at variable intraoral locations and subject to angular force vectors, which may further impact surrounding periodontal tissues.
This cross-sectional clinical study aims to evaluate the effects of orthodontic mini-screw placement on general oral health and periodontal tissue status. The study will investigate site-specific and full-mouth periodontal parameters and explore potential associations between mini-screw stability, soft tissue characteristics, and signs of mucosal inflammation.
Detailed description
Orthodontic mini-screws, also known as temporary anchorage devices (TADs), have become an integral component of modern orthodontic therapy, enabling controlled tooth movement without relying on patient compliance. For optimal clinical success, these devices must maintain mechanical stability throughout the treatment period. Stability is commonly categorized into two types: primary stability, which represents the initial mechanical engagement of the screw with cortical bone, and secondary stability, which depends on bone remodeling and healing processes occurring over time.
Despite their clinical utility, mini-screws are prone to several biological and mechanical challenges that may compromise their stability. Factors such as patient age, gender, cortical bone thickness, screw dimensions, insertion torque, and the magnitude and direction of orthodontic forces are known to affect outcomes. Moreover, local inflammatory responses-particularly in the presence of poor oral hygiene or non-keratinized soft tissue-can lead to tissue breakdown and mini-screw failure. These inflammatory reactions resemble peri-implantitis observed in dental implants and are thought to result in marginal bone loss, especially around the neck of the mini-screw.
Given the biomechanical complexity and variability in intraoral placement, orthodontic mini-screws may provoke localized periodontal changes, even in periodontally healthy individuals. However, limited data are available on how these devices influence surrounding periodontal tissues at both the site level and full-mouth level, particularly during the early healing phase after placement.
This cross-sectional clinical study aims to evaluate the relationship between orthodontic mini-screws and periodontal health three months after screw placement. A total of 132 systemically healthy, non-smoking patients with 160 mini-screw insertions will be included. Clinical parameters such as plaque index (PI), gingival index (GI), probing pocket depth (PPD), recession depth (RD), bleeding on probing (BOP), keratinized tissue width (KTW), supracrestal tissue height (STH), transmucosal soft tissue thickness (phenotype), mucosal redness (MR), and mucosal discomfort (MD) will be measured both site-specifically and at the full-mouth level. In addition, torque gauge (TG) measurements will be used to assess mechanical stability of the mini-screws.
The study aims to identify whether site-specific inflammation and soft tissue characteristics correlate with decreased implant stability or patient-reported discomfort. Results may provide valuable insights into the biological response of periodontal tissues to TADs and help improve clinical protocols for their placement, monitoring, and maintenance.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study included patients who had been treated with orthodontic mini implants at the Department of Orthodontics, Faculty of Dentistry, Altinbas University. A total of 132 patients were included in the study.
Key inclusion criteria (1 listed)
- Systemically healthy individuals; non-smokers; patients undergoing fixed orthodontic treatment requiring mini-screw anchorage; periodontally healthy (bleeding on probing <10%); no clinical signs of gingival inflammation at the time of mini-screw placement; provided written informed consent.
Key exclusion criteria (1 listed)
- History of systemic disease (e.g., diabetes, immunosuppression); current use of antibiotics, corticosteroids, or other medications affecting periodontal health; history of radiation therapy in the head and neck region; poor oral hygiene or visible plaque accumulation at baseline; pregnant or breastfeeding women; presence of active periodontal disease (e.g., PPD >3 mm, BOP >10%); previous orthodontic mini-screw failure in the same site.
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 |
|---|---|---|
| Clinical periodontal assessmentComprehensive site-level and full-mouth evaluations of periodontal parameters, including plaque index (PI), gingival index (GI), probing pocket depth (PPD), recession depth (RD), bleeding on probing (BOP), keratinized tissue width (KTW), mucosal phenotype, mucosal redness (MR), mucosal discomfort (MD), and torque gauge (TG) measurements. | Other | – |
Primary outcome
Probing Pocket Depth (PPD)
Time frame: 3 months after mini-screw placement
Mean PPD measured at six sites around each of the two teeth adjacent to the mini-screw, using a UNC-15 periodontal probe. Values are averaged per site to assess localized periodontal response. This measurement also done for full-mouth teeth.
Plaque Index (PI)
Time frame: 3 months after mini-screw placement
Plaque accumulation assessed visually on the buccal and lingual surfaces of teeth adjacent to the mini-screw and for full-mouth teeth using the Löe and Silness Index. Values averaged across sites.
Gingival Index (GI)
Time frame: 3 months after mini-screw placement
Gingival inflammation assessed using the Löe and Silness Gingival Index at the six surfaces of the adjacent teeth and full mouth seperately. Scores averaged to evaluate site-specific soft tissue response.
Bleeding on Probing (BOP)
Time frame: 3 months after mini-screw placement
Presence or absence of bleeding recorded at six sites per adjacent tooth and full mouth teeth immediately after gentle probing. The percentage of bleeding sites is calculated to assess inflammation.
Gingival Recession Depth (RD)
Time frame: 3 months after mini-screw placement
Distance from the cemento-enamel junction to the free gingival margin measured at six sites of adjacent teeth. Mean values indicate apical migration of the gingiva.
Mucosal Redness (MR)
Time frame: 3 months after mini-screw placement
Clinical assessment of redness in the mucosa surrounding the mini-screw, based on visual inspection. Recorded as present or absent.
Mucosal Discomfort (MD)
Time frame: 3 months after mini-screw placement
Self-reported discomfort or sensitivity around the mini-screw site, recorded during the clinical examination. Binary outcome (present or absent).
Keratinized Tissue Width (KTW)
Time frame: 3 months after mini-screw placement
Horizontal and vertical keratinized tissue widths measured using a periodontal probe in millimeters. Recorded to evaluate soft tissue protection at the site.
Supracrestal Tissue Height (STH)
Time frame: 3 months after mini-screw placement
Vertical height from the alveolar crest to the gingival margin measured at the mini-screw site using a periodontal probe. Indicates soft tissue volume and attachment.
Transmucosal Soft Tissue Thickness (Phenotype)
Time frame: 3 months after mini-screw placement
Measured using a periodontal probe to determine whether the phenotype is thick or thin. Helps assess how mucosal type influences peri-screw tissue response.
Torque Gauge (TG) Value
Time frame: 3 months after mini-screw placement
Stability of each mini-screw measured using a torque gauge. Values recorded in Newtons to assess biomechanical resistance of the screw at 3-month follow-up.
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 7 Jul 2025.
- Background: PubMed 39543578Yildiz MS, Ulutas PA, Ozenci I, Akcali A. Clinical and radiographic assessment of the association between orthodontic mini-screws and periodontal health. BMC Oral Health. 2024 Nov 14;24(1):1376. doi: 10.1186/s12903-024-05136-2.
- Background: PubMed 27692423Parmar R, Reddy V, Reddy SK, Reddy D. Determination of soft tissue thickness at orthodontic miniscrew placement sites using ultrasonography for customizing screw selection. Am J Orthod Dentofacial Orthop. 2016 Oct;150(4):651-658. doi: 10.1016/j.ajodo.2016.03.026.
- Background: PubMed 16849067Park HS, Jeong SH, Kwon OW. Factors affecting the clinical success of screw implants used as orthodontic anchorage. Am J Orthod Dentofacial Orthop. 2006 Jul;130(1):18-25. doi: 10.1016/j.ajodo.2004.11.032.
- Background: PubMed 15367187Zitzmann NU, Berglundh T, Ericsson I, Lindhe J. Spontaneous progression of experimentally induced periimplantitis. J Clin Periodontol. 2004 Oct;31(10):845-9. doi: 10.1111/j.1600-051X.2004.00567.x.
- Background: PubMed 22197573Algraffee H, Borumandi F, Cascarini L. Peri-implantitis. Br J Oral Maxillofac Surg. 2012 Dec;50(8):689-94. doi: 10.1016/j.bjoms.2011.11.020. Epub 2011 Dec 22.
- Background: PubMed 20152674Lee SJ, Ahn SJ, Lee JW, Kim SH, Kim TW. Survival analysis of orthodontic mini-implants. Am J Orthod Dentofacial Orthop. 2010 Feb;137(2):194-9. doi: 10.1016/j.ajodo.2008.03.031.
- Background: PubMed 21612317Ure DS, Oliver DR, Kim KB, Melo AC, Buschang PH. Stability changes of miniscrew implants over time. Angle Orthod. 2011 Nov;81(6):994-1000. doi: 10.2319/120810-711.1. Epub 2011 May 25.
- Background: PubMed 15973954Raghavendra S, Wood MC, Taylor TD. Early wound healing around endosseous implants: a review of the literature. Int J Oral Maxillofac Implants. 2005 May-Jun;20(3):425-31.
- Derived from this study: PubMed 41968715Yildiz MS, Ulutas PA, Akcali A. Periodontal health and orthodontic mini-screws: a cross-sectional study. J Periodontal Implant Sci. 2026 Mar 23. doi: 10.5051/jpis.2503060153. Online ahead of print.
- Individual participant dataSharing planned: No. Researchers can request access to the IPD by contacting Dr. Mehmet Selim Yildiz at "mehmet.yildiz2@altinbas.edu.tr or mehmetselimyildiz4@gmail.com"
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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.
Mehmet Selim YILDIZ, Asst. Prof. principal investigator
Altinbas University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implantation and Peri-implant Mucositis, run by Dr. Mehmet Selim Yildiz 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 1 inclusion and 1 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 7 Jul 2025. 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?
Probing Pocket Depth (PPD) (time frame: 3 months after mini-screw placement). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07052747, which also lists 9 linked publications.
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 7 Jul 2025.