NCT06500559

Brief Summary

Alveolar bone loss and fenestration are the most prevalent bone defects that often result in root exposure, gingival recession, and potential treatment relapse or failure. These issues present complications in orthodontic therapy. Hence, reducing the length of orthodontic therapy and minimizing the occurrence of these serious complications are highly important for orthodontic patients, particularly adults. platelet-rich plasma (PRP) injection and decortication are two promising methods for accelerated tooth movements. Thus, The aim of this study is to evaluate alveolar bone dehiscence and fenestrations after canine retraction, using alveolar decortication and PRP injection as two methods for accelerating tooth movements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2025

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

July 8, 2024

Last Update Submit

September 9, 2025

Conditions

Keywords

accelerated orthodonticsDehiscencefenestrationCBCT

Outcome Measures

Primary Outcomes (2)

  • Alveolar bone dehiscence

    Pre- and post- retraction CBCTs will be obtained from patients. Linear measurement (mm) for dehiscence (LM-D) will be defined as the distance between the alveolar crest to the cementoenamel junction of each root (critical point will be set at 2 mm)

    4 months

  • Alveolar bone fenestration

    Pre- and post- retraction CBCTs will be obtained from patients. Linear measurement (mm) for fenestration (LM-F) will be recorded when the defect involved only the apical one-third of a root (critical point will be set at 2.2 mm)

    4 months

Study Arms (2)

group I: PRP injection

EXPERIMENTAL

Accelerated maxillary canine retraction will be done after PRP injection in one random side of the maxillary arch while the other side serve as control

Procedure: PRP injection

group II: Combined decortication and PRP injection

EXPERIMENTAL

Accelerated maxillary canine retraction will be done after combined decortication and PRP injection in one random side of the maxillary arch while the other side serve as control

Procedure: Combined decortication and PRP injection

Interventions

PRP injectionPROCEDURE

PRP (0.7 ml = 70 unit) will be injected submucosal disto-buccal and disto-palatal to the maxillary canine like the local anesthesia injection in group I experimental sides

group I: PRP injection

Experimental sides will receive PRP injection after performing decortication. After administration of local anesthesia, two-line flap will be performed from the mesial surface of the maxillary second premolar to the distal surface of the maxillary canine Mucoperiosteal flap will be reflected in the buccal side. Two millimeters of marginal crestal bone will be held intact and using a high-speed drill and a round carbide bur (1mm diameter) under copious saline irrigation, the cortical wall will be penetrated to reach marrow spaces. Multiple perforations (10 holes for standardization) in the cortical bone will be created. The surgical site will then rinsed, and the flap will be repositioned and sutured.

group II: Combined decortication and PRP injection

Eligibility Criteria

Age16 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age of the patients ranged from 16: 22 years old.
  • Malocclusion that requires extraction of the maxillary first premolar and canine retraction (e.g. class I bimaxillary dentoalveolar protrusion and class II div 1 malocclusion).
  • Maximum anchorage needed for the maxillary arch as a part of the orthodontic treatment plan.
  • Good oral hygiene and periodontal condition.

You may not qualify if:

  • Medically compromised patients.
  • Severe crowding in the maxillary arch.
  • Chronic intake of NSAIDs or any medication that interfere with OTM.
  • Previous orthodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Tanta, 6624033, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Orthodontics

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 15, 2024

Study Start

May 1, 2024

Primary Completion

February 1, 2025

Study Completion

September 7, 2025

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations