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Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy

ConditionMalocclusion, Angle Class I
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients who are current smokers

Pregnancy

Uncontrolled diabetes or other metabolic systemic conditions

Presence of open bite or deep bite

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Control groupActive comparator 1 intervention

Trial outcomes

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)

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)

PD is the distance from CEJ to base of gingival pocket

Time frame
Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
3

Change in clinical attachment level (CAL)

CAL is the distance between CEJ and base of the pocket

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

Change in width of keratinized tissue (WKT) at alignment

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

American Academy of Periodontology Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: