Comparing of the Clinical Outcome of Periodontal Accelerated Osteogenic Orthodontics With Horizontal or Vertical Releasing Incisions

Zhejiang University

Status: Completed

Conditions: Malocclusion

Treatments: Procedure: horizontal extending incision; Procedure: vertical releasing incision

Study type: Interventional

Funder types: Other

Identifiers

NCT05441683

2022-0271

Details and patient eligibility

About

The study aims to compare the effect of periodontal accelerated osteogenic orthodontics (PAOO) with horizontal or vertical releasing incisions on operation time, healing, adverse effects, and effectiveness of bone augmentation.

Methods: A total of 22 patients requiring PAOO surgery due to orthodontic treatment were enrolled in this trial, and randomly divided into test or control group, consisting of 11 subjects in each. The test group will receive PAOO with horizontal extending incisions on both sides of the flap; while the control group will receive PAOO with vertical releasing incisions; the two groups use the same surgical technic except for the incision design. Outcome measures include: operation time, postoperative scar, radiographic data (alveolar height and alveolar ridge thickness), gingival thickness, etc. Clinical evaluation will be performed at 1 week, 2 weeks, 3months, 6 months and 12 months after operation.

Enrollment: 22 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged between 18 and 40 years old, systemic healthy, undergoing or planning to undergo orthodontic treatment.
2. Patients with a thin alveolar bone or with dehiscence and/or fenestration on the labial side of maxillary or mandibular front teeth area.
3. Patients with expected tooth movement beyond the labial alveolar bone during orthodontic procedures.

Exclusion criteria

1. Smoker.
2. Pregnant or lactating.
3. Untreated periodontitis.
4. Presence of <2mm keratinized gingival width(KGW) or thin gingival phenotype (as defined by dental probe transparency.)
5. History of orthodontic and/or orthognathic treatment.
6. With systemic disease (diabetes, hypertension, heart disease, malignant tumor, severe mental illness, and other surgical contraindications.)
7. Long-term medication (immunosuppressive drugs, bisphosphonates, etc.)
8. Poor adherence to complete one-year follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

HEI group

Experimental group

Description:

PAOO with horizontal extending incisions on both sides

Treatment:

Procedure: horizontal extending incision

VRI group

Active Comparator group

Description:

PAOO with vertical releasing incisions on both sides

Treatment:

Procedure: vertical releasing incision