MalocclusionNCT05441683
Comparing of the Clinical Outcome of Periodontal Accelerated Osteogenic Orthodontics With Horizontal or Vertical Releasing Incisions
A study testing horizontal extending incision and vertical releasing incision in people with Malocclusion, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Malocclusion
- What is being tested?
- horizontal extending incision and vertical releasing incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
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
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.
- Conditions
- Malocclusion
- Being tested
- horizontal extending incision, vertical releasing incision
- Keywords
- periodontal accelerated osteogenic orthodontics, vertical releasing incision
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
horizontal extending incisionProcedure or surgery
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 incisionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| HEI group | Experimental | PAOO with horizontal extending incisions on both sides Receives: Procedure: horizontal extending incision |
| VRI group | Active comparator | PAOO with vertical releasing incisions on both sides Receives: Procedure: vertical releasing incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery 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 surgery time.
Measured: 1 day
Secondary outcomes (15)
Probing Depth (PD)
Distance from gingival margin to base of periodontal pocket. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Measured: 12 months
Clinical Attachment Level (CAL)
Distance from CEJ to base of periodontal pocket. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Measured: 12 months
Keratinized Gingival Width (KGW)
From mucogingival junction to free gingival margin It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Measured: 12 months
Gingival Recession Depth (GRD)
Distance from CEJ to gingival margin. It will be measured at baseline and 3 months, 6 months, and 12months after surgery.
Measured: 12 months
Root Length
the distance from the CEJ to the apex of the root. It will be measured at baseline, 6 months, and 12months after surgery.
Measured: 12 months
Vertical Bone Height (VBL)
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.
Measured: 12 months
Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2)
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.
Measured: 12 months
Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4)
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.
Measured: 12 months
Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6)
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.
Measured: 12 months
Number of Participants With Visible Scarring
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.
Measured: 12 months
Pain Level
measured with visual analogue score (VAS): 0 (no pain/normal sensation) to 10 (intolerable pain/complete numbness)
Measured: 2 weeks
Membrane Exposure
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.
Measured: 2 weeks
Facial Swelling
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.
Measured: 2 weeks
Mucosal Color
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.
Measured: 2 weeks
Mucosa Edema
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start7 Jul 2022
- Primary completion30 Aug 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanmin Wu, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441683
- Sponsor's protocol ID
- 2022-0271
- Status last verified
- Apr 2025
- First submitted
- 13 Jun 2022
- Last updated
- 11 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Chen Y, Jiang K, Bian Z, Chen X, Lin Q, Yang Y, Zhang Z, Li B, Sun G, Tan J, Wu Y. Comparison of vertical releasing incisions and horizontal extending incisions for periodontal accelerated osteogenic orthodontics in the anterior region: a randomized controlled trial with clinical and radiographic outcomes. BMC Oral Health. 2025 Dec 29;25(1):1950. doi: 10.1186/s12903-025-07270-x.
PubMed 41462182
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05441683
- Acronym / sponsor ID
- 2022-0271
- Conditions
- Malocclusion
- Keywords
- periodontal accelerated osteogenic orthodontics, vertical releasing incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 1 Jul 2022 (actual)
- Results
- Posted 11 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEI group | Experimental | Procedure: horizontal extending incisionPAOO with horizontal extending incisions on both sides |
| VRI group | Active comparator | Procedure: vertical releasing incisionPAOO with vertical releasing incisions on both sides |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| horizontal extending incisiona 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. | Procedure or surgery | HEI group |
| vertical releasing incisiona 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. | Procedure or surgery | VRI group |
Primary outcome
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.
15 secondary outcomes
Probing Depth (PD)
Time frame: 12 months
Clinical Attachment Level (CAL)
Time frame: 12 months
Keratinized Gingival Width (KGW)
Time frame: 12 months
Gingival Recession Depth (GRD)
Time frame: 12 months
Root Length
Time frame: 12 months
Vertical Bone Height (VBL)
Time frame: 12 months
Alveolar Bone Width Measured at 2 mm Below the CEJ (BW2)
Time frame: 12 months
Alveolar Bone Width Measured at 4 mm Below the CEJ (BW4)
Time frame: 12 months
Alveolar Bone Width Measured at 6 mm Below the CEJ (BW6)
Time frame: 12 months
Number of Participants With Visible Scarring
Time frame: 12 months
Pain Level
Time frame: 2 weeks
Membrane Exposure
Time frame: 2 weeks
Facial Swelling
Time frame: 2 weeks
Mucosal Color
Time frame: 2 weeks
Mucosa Edema
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41462182Chen Y, Jiang K, Bian Z, Chen X, Lin Q, Yang Y, Zhang Z, Li B, Sun G, Tan J, Wu Y. Comparison of vertical releasing incisions and horizontal extending incisions for periodontal accelerated osteogenic orthodontics in the anterior region: a randomized controlled trial with clinical and radiographic outcomes. BMC Oral Health. 2025 Dec 29;25(1):1950. doi: 10.1186/s12903-025-07270-x.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanmin Wu principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing horizontal extending incision and vertical releasing incision in people with Malocclusion, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery Time (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05441683, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.