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

Sponsors

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

Source Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Overall Status Recruiting
Start Date 2022-06-01
Completion Date 2025-06-30
Primary Completion Date 2024-06-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
surgury time 1 day
Secondary Outcome
Measure Time Frame
probing depth (PD) 12 months
clinical attachment level (CAL) 12 months
keratinized gingival width (KGW) 12 months
gingival recession depth (GRD) 12 months
gingival thickness (GT) 12months
alveolar ridge height 12 months
alveolar ridge horizontal thickness 12 months
facial swelling 2 weeks
pain level 2 weeks
mucosal color 2 weeks
edema 2 weeks
membrane exposure 2 weeks
Enrollment 22
Condition
Intervention

Intervention Type: Procedure

Intervention Name: horizontally extending incision

Description: 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.

Arm Group Label: HEI

Intervention Type: Procedure

Intervention Name: vertical releasing incision

Description: 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.

Arm Group Label: VRI

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

40 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Yanmin Wu Principal Investigator 2nd Affiliated Hospital, School of Medicine, Zhejiang University
Overall Contact

Last Name: Yanmin Wu

Phone: +86 0571 87783607

Email: [email protected]

Location
Facility: Status: Contact: 2nd Affiliated Hospital, School of Medicine, Zhejiang University Yanmin Wu +86 0571 87783607 [email protected]
Location Countries

China

Verification Date

2022-05-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: HEI

Type: Experimental

Description: PAOO with horizontally extending incisions on both sides

Label: VRI

Type: Active Comparator

Description: PAOO with vertical releasing incisions on both sides

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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