NCT07052747|Completed
Periodontal Effects of Orthodontic Mini-Screws
Periodontal Health and Orthodontic Mini-screws: A Cross-sectional Study
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Periodontal Health and Orthodontic Mini-screws: A Cross-sectional Study
Sponsor study identifier
observational
132
1 country
1
Study Start
October 4, 2024
Actual (reported)Primary Completion
April 25, 2025
Actual (reported)Study Completion
April 29, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 29, 2025
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 4, 2024
Actual (reported)April 25, 2025
Actual (reported)April 29, 2025
Actual (reported)June 29, 2025
Actual (reported)July 7, 2025
Actual (reported)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.
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.
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.
3 months after mini-screw placement
Bleeding on Probing (BOP)
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Altinbas University, Faculty of Dentistry
Istanbul, Bakırköy, 34147, Turkey (Türkiye)
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.
Parmar 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.
Mehmet Selim YILDIZ, Asst. Prof.
Altinbas University, Faculty of Dentistry
132 participants (actual enrollment reported by the registry).
First Submitted
June 29, 2025
First Posted
July 7, 2025
Study Start
October 4, 2024
Actual (reported)CBCT Assessment of Marginal Bone Changes With Ozone Therapy
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.
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.
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.
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).
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.
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.
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.
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.
3 months after mini-screw placement
Contact the study team to confirm eligibility.
Park 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.
Zitzmann 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.
Algraffee 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.
Lee 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.
Ure 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.
Raghavendra 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.
Yildiz 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.
Primary Completion
April 25, 2025
Actual (reported)Study Completion
April 29, 2025
Actual (reported)Last Updated
July 7, 2025
Record last verified: 2025-06
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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Source: ClinicalTrials.gov.
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