Periodontal Effects of Orthodontic Mini-Screws

NCT07052747 | Completed

• 1 other identifier: 2024/30
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dental Implantation; Peri-implant Mucositis; Orthodontic Anchorage Procedures; Gingival Inflammation and Bleeding

Outcome Measures

Primary Outcomes (11)

• 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)

  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

Interventions

Clinical periodontal assessment OTHER

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Mehmet Selim Yildiz: lead

Study Sites (1)

Altinbas University, Faculty of Dentistry

Istanbul, Bakırköy, 34147, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 39543578 BACKGROUND

• 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.

  PMID: 27692423 BACKGROUND

• 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.

  PMID: 16849067 BACKGROUND

• 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.

  PMID: 15367187 BACKGROUND

• 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.

  PMID: 22197573 BACKGROUND

• 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.

  PMID: 20152674 BACKGROUND

• 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.

  PMID: 21612317 BACKGROUND

• 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.

  PMID: 15973954 BACKGROUND

MeSH Terms

Conditions

Gingivitis; Hemorrhage

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mehmet Selim YILDIZ, Asst. Prof.

  Altinbas University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Dr.

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 7, 2025
• Study Start: October 4, 2024
• Primary Completion: April 25, 2025
• Study Completion: April 29, 2025
• Last Updated: July 7, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)