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

Study Overview
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Brief Summary
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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.

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

Conditions
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Malocclusion

Intervention / Treatment
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* Procedure: horizontally extending incision
* Procedure: vertical releasing incision


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEI<br>PAOO with horizontally extending incisions on both sides | Procedure: horizontally extending incision<br>* 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.<br>|
| Active Comparator: VRI<br>PAOO with vertical releasing incisions on both sides | Procedure: vertical releasing incision<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontal accelerated osteogenic orthodontics, vertical releasing incision