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NCT Number: NCT07445555

Gingival Recessions in Orthodontically Treated and Untreated Adult Patients

To identify the predisposing parameters for gingival recessions in adult patients seeking orthodontic treatment. The ultimate aim is to provide a clinical guideline to estimate the risk of developing post-orthodontic gingival recessions.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Orthodontic Treatment Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The etiology of gingival recessions is yet to be fully understood and is very likely multifactorial, with the involved parameters not necessarily acting simultaneously or in equal extent. The most common etiologic factor would be dental plaque accumulation followed by traumatic tooth brushing, areas with thin, minimal or no keratinized tissue, smoking, malocclusion, dental trauma and high frenal attachment. The labial aspect of the mandibular incisors and maxillary molars is the most often affected by gingival recessions. These contributing factors identified in literature could be grouped in six main categories: age-related, population-related, site-related, mechanical factors, periodontal condition and iatrogenic factors, like orthodontic treatment.

Although quantifying the influence of each factor is very difficult, the association between gingival recessions and orthodontic treatment as an iatrogenic factor has been repeatedly suggested. Given the increasing amount of adult patients seeking orthodontic treatment, the aim of this study is to identify the predisposing parameters for gingival recessions in adult patients, seeking orthodontic treatment. The ultimate aim is to provide a clinical guideline to estimate the risk of developing post-orthodontic gingival recessions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with or without previous history of orthodontic treatment with and without gingival recessions
  • ≥ 18 years old
  • American Society of Anesthesiologists Classification I or II

Exclusion criteria

  • Patients with history of periodontal disease
  • taking the following medication: anticoagulants, phenytoin, cyclosporine, nifedipine or calcium channel blockers
  • Patients with prior history of radio or chemotherapy
  • Pregnant or breastfeeding patients
  • Patients with agenesis of one or more lower incisors

Exclusion criteria

Patients with history of periodontal disease Patients taking the following medication: anticoagulants, phenytoin, cyclosporine, nifedipine or calcium channel blockers Patients with prior history of radio or chemotherapy Pregnant or breastfeeding patients Patients with agenesis of one or more lower incisors

Treatment and study plan

Registration of parameters

Other

De gingival and occlusal parameters will be recorded for the 4 different cohort groups

Primary outcomes

  1. Gingival parameters

    Time frame: 6 months

    Presence of Recessions (Location and extension): in mm (0 to 9)

  2. Periodontal phenotype:

    Time frame: 6 months

    measured from 0.01 to 9.00 (Biometric Ultrasound Scanner)

  3. Full Mouth Bleeding scores (FMBS)

    Time frame: 6 months

    In % of total sites (0 to 100)

  4. Full Mouth Plaque Score (FMPS)

    Time frame: 6 months

    In % of total sites (0 to 100)

  5. Occlusion

    Time frame: 6 months

    Assessed as: N.A, 1 DO, 3/4 DO, 1/2 DO,1/4 DO, NO, 1/4 MO, 1/2 MO, 3/4 MO, 1 MO

  6. Occlusal contact points

    Time frame: 6 months

    Measured in mm ( 0.0 to 3.0)

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Castro

CONTACT

[email protected]

+3216332407

Maria Cadenas

CONTACT

[email protected]

+3216332407

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Gingival Recessions in Orthodontically Treated and Untreated Adult Patients: a Prospective Study

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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