Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy

NCT06627829 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: HSC-DB-24-0478
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malocclusion, Angle Class I

Keywords

orthodontic treatment

Outcome Measures

Primary Outcomes (5)

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

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

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

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

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

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

• Change in volume of three dimensional bone

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

• Change in volume of three dimensional soft tissue

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

Secondary Outcomes (4)

• Change in vertical bone level (VBL)from the CEJ

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

• Change in probing depth (PD)

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

• Change in clinical attachment level (CAL)

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

• Change in width of keratinized tissue (WKT) at alignment

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

Study Arms (3)

Group A

EXPERIMENTAL

Device: Surgically facilitated orthodontics therapy (SFOT) using allograft

Group B

EXPERIMENTAL

Device: Surgically facilitated orthodontics therapy (SFOT) using xenograft

Control group

ACTIVE COMPARATOR

Device: Usual care

Interventions

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.

Group A

Surgically facilitated orthodontics therapy (SFOT) using xenograft DEVICE

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

Group B

Usual care DEVICE

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• American Academy of Periodontology Foundation: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77479, United States

Location

MeSH Terms

Conditions

Malocclusion, Angle Class I

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Sahar Dowlatshahi, DDS, MMSc

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sahar Dowlatshahi, DDS, MMSc

CONTACT

(713) 486-4074; Sahar.Dowlatshahi@uth.tmc.edu

Nikola Angelov

CONTACT

(713) 486-4073; Nikola.Angelov@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 4, 2024
• Study Start: January 6, 2025
• Primary Completion: January 6, 2026
• Study Completion (Estimated): January 6, 2027
• Last Updated: October 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)