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

Primary Purpose

Malocclusion

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
horizontally extending incision
vertical releasing incision
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring periodontal accelerated osteogenic orthodontics, vertical releasing incision

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HEI

VRI

Arm Description

PAOO with horizontally extending incisions on both sides

PAOO with vertical releasing incisions on both sides

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 13, 2022
Last Updated
February 12, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05441683
Brief Title
Comparing of the Clinical Outcome of Periodontal Accelerated Osteogenic Orthodontics With Horizontal or Vertical Releasing Incisions
Official Title
Comparing of the Clinical Outcome of Periodontal Accelerated Osteogenic Orthodontics (PAOO) With Horizontal or Vertical Releasing Incisions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
periodontal accelerated osteogenic orthodontics, vertical releasing incision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HEI
Arm Type
Experimental
Arm Description
PAOO with horizontally extending incisions on both sides
Arm Title
VRI
Arm Type
Active Comparator
Arm Description
PAOO with vertical releasing incisions on both sides
Intervention Type
Procedure
Intervention Name(s)
horizontally extending incision
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
vertical releasing incision
Intervention 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.
Primary Outcome Measure Information:
Title
surgury time
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
probing depth (PD)
Description
It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Time Frame
12 months
Title
clinical attachment level (CAL)
Description
It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Time Frame
12 months
Title
keratinized gingival width (KGW)
Description
It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Time Frame
12 months
Title
gingival recession depth (GRD)
Description
It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Time Frame
12 months
Title
gingival thickness (GT)
Description
gingival phenotype as defined by dental probe transparency
Time Frame
12months
Title
alveolar ridge height
Description
The height of the alveolar ridge, which is measured on CBCT from the most coronal point to the root apex.
Time Frame
12 months
Title
alveolar ridge horizontal thickness
Description
measured on CBCT at the most coronal section, and 2mm, 4mm to the most coronal point, denoted as BW0, BW2, and BW4
Time Frame
12 months
Title
facial swelling
Description
recorded "0" for no facial swelling; "1" for mild facial swelling; "2" for severe facial swelling.
Time Frame
2 weeks
Title
pain level
Description
measured with VAS score
Time Frame
2 weeks
Title
mucosal color
Description
recorded "0" for no redness along the incision; "1" for slight redness; "2" for obvious redness.
Time Frame
2 weeks
Title
edema
Description
recorded "0" for no edema around the surgery area; "1" for mild edema; "2" for severe edema.
Time Frame
2 weeks
Title
membrane exposure
Description
recorded "0" if there is no membrane exposure, and "1" if there is any membrane exposure.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanmin Wu
Phone
+86 0571 87783607
Email
wuyanmin@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanmin Wu
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanmin Wu
Phone
+86 0571 87783607
Email
wuyanmin@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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