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Completed

NCT Number: NCT05441683

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

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.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

horizontal extending incision

Procedure

a papilla preserving 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 initial incision, extending one to two teeth beyond the defected area, before a full-thickness flap is lifted.

vertical releasing incision

Procedure

a papilla preserving 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 initial incision before a full-thickness flap is lifted. The incision formed an oblique trapezoidal flap with a wider base.

Primary outcomes

  1. Surgery Time

    Time frame: 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 outcomes

  1. Probing Depth (PD)

    Time frame: 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.

  2. Clinical Attachment Level (CAL)

    Time frame: 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.

  3. Keratinized Gingival Width (KGW)

    Time frame: 12 months

    From mucogingival junction to free gingival margin It will be measured at baseline and 3 months, 6 months, and 12months after surgery.

  4. Gingival Recession Depth (GRD)

    Time frame: 12 months

    Distance from CEJ to gingival margin. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.

  5. Root Length

    Time frame: 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.

  6. Vertical Bone Height (VBL)

    Time frame: 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.

  7. Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2)

    Time frame: 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.

  8. Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4)

    Time frame: 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.

  9. Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6)

    Time frame: 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.

  10. Number of Participants With Visible Scarring

    Time frame: 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.

  11. Pain Level

    Time frame: 2 weeks

    measured with visual analogue score (VAS): 0 (no pain/normal sensation) to 10 (intolerable pain/complete numbness)

  12. Membrane Exposure

    Time frame: 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.

  13. Facial Swelling

    Time frame: 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.

  14. Mucosal Color

    Time frame: 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.

  15. Mucosa Edema

    Time frame: 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.

Other outcomes

  1. Particulate Bone Grafting Material Weight

    Time frame: 1 day

    The net weight of the bone graft material before surgery is recorded as W1. After surgery, the remaining bone graft material was collected, dried, and weighed by the same electronic scale as W2. The amount of bone graft material used during surgery was calculated as ΔW=W1-W2.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 1, 2022
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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