Clinical trial NCT05441683: Comparing of the Clinical Outcome of Periodontal Accelerated Osteogenic Orthodontics With Horizontal or Vertical Releasing Incisions
Official title: Comparison of Vertical Releasing Incisions and Horizontal Extending Incisions for Periodontal Accelerated Osteogenic Orthodontics in the Anterior Region: A Randomized Controlled Trial With Surgical Time, Clinical and Radiographic Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Keywords: periodontal accelerated osteogenic orthodontics
vertical releasing incision
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Surgery Time
timeFrame: 1 day
Secondary outcomes:
measure: Probing Depth (PD)
timeFrame: 12 months
measure: Clinical Attachment Level (CAL)
timeFrame: 12 months
measure: Keratinized Gingival Width (KGW)
timeFrame: 12 months
measure: Gingival Recession Depth (GRD)
timeFrame: 12 months
measure: Root Length
timeFrame: 12 months
measure: Vertical Bone Height (VBL)
timeFrame: 12 months
measure: Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2)
timeFrame: 12 months
measure: Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4)
timeFrame: 12 months
measure: Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6)
timeFrame: 12 months
measure: Number of Participants With Visible Scarring
timeFrame: 12 months
measure: Pain Level
timeFrame: 2 weeks
measure: Membrane Exposure
timeFrame: 2 weeks
measure: Facial Swelling
timeFrame: 2 weeks
measure: Mucosal Color
timeFrame: 2 weeks
measure: Mucosa Edema
timeFrame: 2 weeks
Other outcomes:
measure: Particulate Bone Grafting Material Weight
timeFrame: 1 day
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
name: Yanmin Wu
role: PRINCIPAL_INVESTIGATOR
References: