Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy

October 2, 2024 updated by: Sahar Dowlatshahi, The University of Texas Health Science Center, Houston

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Device: Surgically facilitated orthodontics therapy (SFOT) using allograft
Participants will receive Surgically facilitated orthodontics therapy (SFOT) along with bone grafting using particulate allograft and collagen membrane, prior to orthodontics treatment.
Active Comparator: Control group
Device: Usual care
Participants will have conventional orthodontics treatment with Invisalign aligners, without any surgical intervention
Experimental: Group B
Device: Surgically facilitated orthodontics therapy (SFOT) using xenograft
Participants will receive SFOT using particulate xenograft and collagen membrane, prior to orthodontics treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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
Time Frame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
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
Time Frame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
Change in volume of three dimensional bone
Time Frame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
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)
from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in vertical bone level (VBL)from the CEJ
Time Frame: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
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
Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
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
Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
Change in width of keratinized tissue (WKT) at alignment
Time Frame: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

American Academy of Periodontology Foundation

Investigators

  • Principal Investigator: Sahar Dowlatshahi, DDS, MMSc, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 6, 2025

Primary Completion (Estimated)

January 6, 2026

Study Completion (Estimated)

January 6, 2027

Study Registration Dates

First Submitted

October 2, 2024

First Submitted That Met QC Criteria

October 2, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

October 4, 2024

Last Update Submitted That Met QC Criteria

October 2, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-DB-24-0478

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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