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

Not Applicable

Completed

Conditions: Malocclusion

Interventions: Procedure: vertical releasing incision
Procedure: horizontally extending incision

Registration Number: NCT05441683

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

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 22

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VRI	vertical releasing incision	PAOO with vertical releasing incisions on both sides
HEI	horizontally extending incision	PAOO with horizontally extending incisions on both sides

Primary Outcome Measures

Name	Time	Method
Surgery Time	1 day	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 surgery time.

Secondary Outcome Measures

Name	Time	Method
Root Length	12 months	the distance from the CEJ to the apex of the root. It will be measured at baseline, 6 months, and 12months after surgery.
Vertical Bone Height (VBL)	12 months	the distance from the cemento-enamel junction to the crest of the labial alveolar bone. It will be measured at baseline, 6 months, and 12months after surgery.
Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2)	12 months	Alveolar bone width measured at 2 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery.
Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4)	12 months	Alveolar bone width measured at 4 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery.
Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6)	12 months	Alveolar bone width measured at 6 mm below the CEJ on the labial side of the alveolar bone, representing the distance from the tooth root surface to the labial bone surface.It will be measured at baseline, 6 months, and 12months after surgery.
Number of Participants With Visible Scarring	12 months	Gingival scarring was evaluated at 12 months postoperatively through visual inspection. Participants were classified as scar-positive if any visible scar was present at the surgical site, including normotrophic scars (flat and white) and pathological scars (raised or irregular in shape). Each participant was counted once regardless of scar characteristics.
Pain Level	2 weeks	measured with visual analogue score (VAS): 0 (no pain/normal sensation) to 10 (intolerable pain/complete numbness)
Membrane Exposure	2 weeks	membrane exposure was observed and assessed as a binary outcome (yes/no). Recorded "no" if there is no membrane exposure, and "yes" if there is any membrane exposure.
Facial Swelling	2 weeks	recorded "0" for no facial swelling; "1" for mild facial swelling; "2" for severe facial swelling. It will be measured at 1 and 2 weeks after surgery.
Mucosal Color	2 weeks	recorded "0" for no redness along the incision; "1" for slight redness; "2" for obvious redness. It will be measured at 1 and 2 weeks after surgery.
Mucosa Edema	2 weeks	recorded "0" for no edema around the surgery area; "1" for mild edema; "2" for severe edema.It will be measured at 1 and 2 weeks after surgery.
Gingival Recession Depth (GRD)	12 months	Distance from CEJ to gingival margin. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Probing Depth (PD)	12 months	Distance from gingival margin to base of periodontal pocket. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Clinical Attachment Level (CAL)	12 months	Distance from CEJ to base of periodontal pocket. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Keratinized Gingival Width (KGW)	12 months	From mucogingival junction to free gingival margin It will be measured at baseline and 3 months, 6 months, and 12months after surgery.