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NCT Number: NCT06627829

Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy

The purpose of this study is to quantitatively investigate the radiographic changes of alveolar bone, and gingival tissue changes of the mandibular anterior teeth in experimental group A receiving SFOT using freeze-dried allograft with a collagen membrane, experimental group B receiving SFOT using particulate xenograft covered by a collagen membrane and control group receiving only orthodontics therapy.

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Key information

Conditions

Malocclusion, Angle Class I Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists (ASA) I/II
  • Periodontal diagnosis of clinical gingival health or gingivitis on intact/reduced periodontium per 2017 American Academy of Periodontology (AAP) classification
  • No history of periodontitis.
  • Class I malocclusion
  • Crowding of 4 mm or less on mandibular anterior incisors
  • Incisor mandibular plane angle between 90-100 degrees
  • No extractions indicated as part of the orthodontic treatment plan
  • Keratinized tissue of at least 3mm

Exclusion criteria

  • Patients who are current smokers
  • Pregnancy
  • Uncontrolled diabetes or other metabolic systemic conditions
  • Presence of open bite or deep bite
  • Spacing
  • Excessive retroclined mandibular incisors
  • Any contraindication to treatment or the material used if in the experimental groups

Treatment and study plan

Surgically facilitated orthodontics therapy (SFOT) using allograft

Device

Participants will receive Surgically facilitated orthodontics therapy (SFOT) along with bone grafting using particulate allograft and collagen membrane, prior to orthodontics treatment.

Surgically facilitated orthodontics therapy (SFOT) using xenograft

Device

Participants will receive SFOT using particulate xenograft and collagen membrane, prior to orthodontics treatment.

Usual Care

Device

Participants will have conventional orthodontics treatment with Invisalign aligners, without any surgical intervention

Primary outcomes

  1. Change in horizontal bone thickness at the 3mm point from Cementoenamel junction (CEJ) (crestal level) on the mandibular incisors

    Time frame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)

  2. Change in horizontal bone thickness at the 6mm point from CEJ (middle level) on the mandibular incisors

    Time frame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)

  3. Change in horizontal bone thickness at the 9mm point from CEJ (apical level) on the mandibular incisors

    Time frame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)

  4. Change in volume of three dimensional bone

    Time frame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)

  5. Change in volume of three dimensional soft tissue

    Time frame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)

Secondary outcomes

  1. Change in vertical bone level (VBL)from the CEJ

    Time frame: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).

  2. Change in probing depth (PD)

    Time frame: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).

    PD is the distance from CEJ to base of gingival pocket

  3. Change in clinical attachment level (CAL)

    Time frame: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).

    CAL is the distance between CEJ and base of the pocket

  4. Change in width of keratinized tissue (WKT) at alignment

    Time frame: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).

Study contacts

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

Nikola Angelov

CONTACT

[email protected]

(713) 486-4073

Sahar Dowlatshahi, DDS, MMSc

CONTACT

[email protected]

(713) 486-4074

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • American Academy of Periodontology Foundation

Registry information

Official study title

Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy: a Randomized Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 4, 2024
Registry last updated
Oct 4, 2024

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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