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

Comparison of Vertical Releasing Incisions and Horizontal Extending Incisions for Periodontal Accelerated Osteogenic Orthodontics in the Anterior Region: A Randomized Controlled Trial With Surgical Time, Clinical and Radiographic Outcomes

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: Completed
• Conditions: Malocclusion
• Intervention / Treatment: Procedure: horizontal extending incision; Procedure: vertical releasing incision

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

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • 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

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 Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEI group; PAOO with horizontal extending incisions on both sides	Procedure: 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.
Active Comparator: VRI group; PAOO with vertical releasing incisions on both sides	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing Depth (PD)	Distance from gingival margin to base of periodontal pocket. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.	12 months
Clinical Attachment Level (CAL)	Distance from CEJ to base of periodontal pocket. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.	12 months
Keratinized Gingival Width (KGW)	From mucogingival junction to free gingival margin It will be measured at baseline and 3 months, 6 months, and 12months after surgery.	12 months
Gingival Recession Depth (GRD)	Distance from CEJ to gingival margin. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.	12 months
Root Length	the distance from the CEJ to the apex of the root. It will be measured at baseline, 6 months, and 12months after surgery.	12 months
Vertical Bone Height (VBL)	the distance from the cemento-enamel junction to the crest of the labial alveolar bone. It will be measured at baseline, 6 months, and 12months after surgery.	12 months
Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2)	Alveolar bone width measured at 2 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery.	12 months
Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4)	Alveolar bone width measured at 4 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery.	12 months
Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6)	Alveolar bone width measured at 6 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery.	12 months
Number of Participants With Visible Scarring	Gingival scarring was evaluated at 12 months postoperatively through visual inspection. Participants were classified as scar-positive if any visible scar was present at the surgical site, including normotrophic scars (flat and white) and pathological scars (raised or irregular in shape). Each participant was counted once regardless of scar characteristics.	12 months
Pain Level	measured with visual analogue score (VAS): 0 (no pain/normal sensation) to 10 (intolerable pain/complete numbness)	2 weeks
Membrane Exposure	membrane exposure was observed and assessed as a binary outcome (yes/no). Recorded "no" if there is no membrane exposure, and "yes" if there is any membrane exposure.	2 weeks
Facial Swelling	recorded "0" for no facial swelling; "1" for mild facial swelling; "2" for severe facial swelling. It will be measured at 1 and 2 weeks after surgery.	2 weeks
Mucosal Color	recorded "0" for no redness along the incision; "1" for slight redness; "2" for obvious redness. It will be measured at 1 and 2 weeks after surgery.	2 weeks
Mucosa Edema	recorded "0" for no edema around the surgery area; "1" for mild edema; "2" for severe edema.It will be measured at 1 and 2 weeks after surgery.	2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Particulate Bone Grafting Material Weight	The net weight of the bone graft material before surgery is recorded as W1. After surgery, the remaining bone graft material was collected, dried, and weighed by the same electronic scale as W2. The amount of bone graft material used during surgery was calculated as ΔW=W1-W2.	1 day

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Yanmin Wu, 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): December 30, 2024

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 (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

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