Clinical trial NCT06627829: Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy
Official title: Effect of Different Grafting Material Following Surgically Facilitated Orthodontics Therapy: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malocclusion, Angle Class I
Keywords: orthodontic treatment
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: American Academy of Periodontology Foundation
First posted: 2024-10-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in horizontal bone thickness at the 3mm point from Cementoenamel junction (CEJ) (crestal level) on the mandibular incisors
timeFrame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
measure: Change in horizontal bone thickness at the 6mm point from CEJ (middle level) on the mandibular incisors
timeFrame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
measure: Change in horizontal bone thickness at the 9mm point from CEJ (apical level) on the mandibular incisors
timeFrame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
measure: Change in volume of three dimensional bone
timeFrame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
measure: Change in volume of three dimensional soft tissue
timeFrame: from baseline to endpoint (Alignment visit, approximately 4 months after the start of orthodontics treatment)
Secondary outcomes:
measure: Change in vertical bone level (VBL)from the CEJ
timeFrame: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
measure: Change in probing depth (PD)
timeFrame: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
measure: Change in clinical attachment level (CAL)
timeFrame: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
measure: Change in width of keratinized tissue (WKT) at alignment
timeFrame: Baseline, at alignment (approximately 4 months after the start of orthodontics treatment).
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sahar Dowlatshahi, DDS, MMSc
role: PRINCIPAL_INVESTIGATOR
References: