N/A
N=22
Comparing of the Clinical Outcome of Periodontal Accelerated Osteogenic Orthodontics With Horizontal or Vertical Releasing Incisions
Malocclusion
Bottom Line
View on ClinicalTrials.gov: NCT05441683 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Surgery Time — 57.66; 68.50 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- horizontal extending incision (Procedure); vertical releasing incision (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgery Time |
57.66; 68.50 | — |
| SECONDARY Probing Depth (PD) |
1.86; 1.86; -0.05; 0.06; 0.03; 0.13 | — |
| SECONDARY Clinical Attachment Level (CAL) |
0.66; 0.52; 0.05; 0.05; 0.01; 0.16 | — |
| SECONDARY Keratinized Gingival Width (KGW) |
2.97; 3.50; 0.50; 0.07; 0.37; 0.41 | — |
| SECONDARY Gingival Recession Depth (GRD) |
-0.75; -0.96; -0.06; 0.14; -0.08; 0.21 | — |
| SECONDARY Root Length |
11.11; 12.03; -0.30; -0.45; -0.44; -064 | — |
| SECONDARY Vertical Bone Height (VBL) |
4.28; 5.06; -2.95; -3.17; -2.69; -2.94 | — |
| SECONDARY Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2) |
0.33; 0.18; 0.80; 0.45; 0.67; 0.39 | — |
| SECONDARY Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4) |
0.43; 0.39; 1.71; 0.96; 1.44; 0.94 | — |
| SECONDARY Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6) |
0.45; 0.51; 2.47; 1.38; 1.92; 1.13 | — |
| SECONDARY Number of Participants With Visible Scarring |
1; 6 | — |
| SECONDARY Pain Level |
2.90; 2.70; 1.60; 1.50 | — |
| SECONDARY Membrane Exposure |
3; 1; 7; 9 | — |
| SECONDARY Facial Swelling |
6; 4; 4; 6; 0; 0 | — |
| SECONDARY Mucosal Color |
0; 0; 10; 9; 0; 1 | — |
| SECONDARY Mucosa Edema |
1; 0; 7; 6; 2; 4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05441683). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.