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

Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05441683
• Other study ID #: 2022-0271
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yanmin Wu
• Phone: +86 0571 87783607
• Email: wuyanmin[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	probing depth (PD)	It will be measured at baseline and 3 months, 6 months, and 12months after surgery.	12 months
Secondary	clinical attachment level (CAL)	It will be measured at baseline and 3 months, 6 months, and 12months after surgery.	12 months
Secondary	keratinized gingival width (KGW)	It will be measured at baseline and 3 months, 6 months, and 12months after surgery.	12 months
Secondary	gingival recession depth (GRD)	It will be measured at baseline and 3 months, 6 months, and 12months after surgery.	12 months
Secondary	gingival thickness (GT)	gingival phenotype as defined by dental probe transparency	12months
Secondary	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
Secondary	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
Secondary	facial swelling	recorded "0" for no facial swelling; "1" for mild facial swelling; "2" for severe facial swelling.	2 weeks
Secondary	pain level	measured with VAS score	2 weeks
Secondary	mucosal color	recorded "0" for no redness along the incision; "1" for slight redness; "2" for obvious redness.	2 weeks
Secondary	edema	recorded "0" for no edema around the surgery area; "1" for mild edema; "2" for severe edema.	2 weeks
Secondary	membrane exposure	recorded "0" if there is no membrane exposure, and "1" if there is any membrane exposure.	2 weeks