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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Malocclusion
• Intervention / Treatment: Procedure: horizontally extending incision; Procedure: vertical releasing incision

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HEI; PAOO with horizontally extending incisions on both sides	Procedure: horizontally extending incision; An intrasulcular 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 Intrasulcular incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.
ACTIVE_COMPARATOR: VRI; PAOO with vertical releasing incisions on both sides	Procedure: vertical releasing incision; An intrasulcular 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 intrasulcular incision before a full-thickness flap is lifted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgury 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 surgury time.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
probing depth (PD)	It will be measured at baseline and 3 months, 6 months, and 12months after surgery.	12 months
clinical attachment level (CAL)	It will be measured at baseline and 3 months, 6 months, and 12months after surgery.	12 months
keratinized gingival width (KGW)	It will be measured at baseline and 3 months, 6 months, and 12months after surgery.	12 months
gingival recession depth (GRD)	It will be measured at baseline and 3 months, 6 months, and 12months after surgery.	12 months
gingival thickness (GT)	gingival phenotype as defined by dental probe transparency	12months
alveolar ridge height	The height of the alveolar ridge, which is measured on CBCT from the most coronal point to the root apex.	12 months
alveolar ridge horizontal thickness	measured on CBCT at the most coronal section, and 2mm, 4mm to the most coronal point, denoted as BW0, BW2, and BW4	12 months
facial swelling	recorded "0" for no facial swelling; "1" for mild facial swelling; "2" for severe facial swelling.	2 weeks
pain level	measured with VAS score	2 weeks
mucosal color	recorded "0" for no redness along the incision; "1" for slight redness; "2" for obvious redness.	2 weeks
edema	recorded "0" for no edema around the surgery area; "1" for mild edema; "2" for severe edema.	2 weeks
membrane exposure	recorded "0" if there is no membrane exposure, and "1" if there is any membrane exposure.	2 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2022
• Primary Completion (ANTICIPATED): June 30, 2024
• Study Completion (ANTICIPATED): June 30, 2025

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (ACTUAL): July 1, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 12, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: periodontal accelerated osteogenic orthodontics; vertical releasing incision
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 2022-0271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No