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

NCT ID: NCT05441683

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-07
• Study Completion Date: 2024-12-30

Brief Summary

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.

Conditions

Malocclusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HEI group

PAOO with horizontal extending incisions on both sides

Group Type: EXPERIMENTAL

horizontal extending incision

Intervention Type: PROCEDURE

a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.

VRI group

PAOO with vertical releasing incisions on both sides

Group Type: ACTIVE_COMPARATOR

vertical releasing incision

Intervention Type: PROCEDURE

a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Interventions

horizontal extending incision

a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Then horizontally extending incisions will be added to each side of the initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.

Intervention Type: PROCEDURE

vertical releasing incision

a papilla preserving incision will be made on the labial side of the front teeth with a thin alveolar bone or dehiscence and/or fenestration. Vertical releasing incisions will be made on each side of the initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanmin Wu

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2022-0271

Identifier Type: -

Identifier Source: org_study_id