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

NCT05441683 | Completed Results

• 1 other identifier: 2022-0271
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

periodontal accelerated osteogenic orthodontics; vertical releasing incision

Outcome Measures

Primary Outcomes (1)

• Surgery Time

  Timing will start when the first incision is about to be made, and end when the last suture is complete. The time in between will be recorded as surgery time.

  1 day

Secondary Outcomes (15)

• Probing Depth (PD)

  12 months

• Clinical Attachment Level (CAL)

  12 months

• Keratinized Gingival Width (KGW)

  12 months

• Gingival Recession Depth (GRD)

  12 months

• Root Length

  12 months

Other Outcomes (1)

• Particulate Bone Grafting Material Weight

  1 day

Study Arms (2)

HEI group

EXPERIMENTAL

PAOO with horizontal extending incisions on both sides

Procedure: horizontal extending incision

VRI group

ACTIVE COMPARATOR

PAOO with vertical releasing incisions on both sides

Procedure: vertical releasing incision

Interventions

horizontal extending incision 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.

HEI group

vertical releasing incision 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.

VRI group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Yan-Min Wu
• Organization: Department of Periodontology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China

wuyanmin@zju.edu.cn

+86-13757119560

Study Officials

• Yanmin Wu

  2nd Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: July 1, 2022
• Study Start: July 7, 2022
• Primary Completion: August 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 11, 2025
• Results First Posted: May 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)