Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy

NCT ID: NCT06627829

Last Updated: 2024-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-06

Study Completion Date

2027-01-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malocclusion, Angle Class I

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

Group Type EXPERIMENTAL

Surgically facilitated orthodontics therapy (SFOT) using allograft

Intervention Type DEVICE

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

Group B

Group Type EXPERIMENTAL

Surgically facilitated orthodontics therapy (SFOT) using xenograft

Intervention Type DEVICE

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

Control group

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Surgically facilitated orthodontics therapy (SFOT) using xenograft

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

Intervention Type DEVICE

Usual care

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

American Academy of Periodontology Foundation

UNKNOWN

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sahar Dowlatshahi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sahar Dowlatshahi, DDS, MMSc

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sahar Dowlatshahi, DDS, MMSc

Role: CONTACT

(713) 486-4074

Nikola Angelov

Role: CONTACT

(713) 486-4073

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sahar Dowlatshahi, DDS, MMSc

Role: primary

(713) 486-4074

Nikola Angelov

Role: backup

(713) 486-4073

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSC-DB-24-0478

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Digital Bonding vs. Direct Bonding Study
NCT06266130 ENROLLING_BY_INVITATION NA