NCT02796911

Brief Summary

Objective: Periodontally accelerated osteogenic orthodontics(PAOO) will minimize treatment time. The current study will be carried to evaluate the effectiveness of different bone grafts with a modified, less invasive corticotomy technique in the treatment of adult patients with moderate crowding. Subjects and Methods: Thirty orthodontic patients will be selected. Patients were randomly classified into three groups. Group I will be treated with a modified technique of corticotomy, whereas group II will be treated with the same technique combined with PAOO using bovine derived xenograft, and group III will be treated with the same technique combined with PAOO using with bioactive glass. The total duration of active orthodontic treatment will be estimated. Probing depth, bone density and root length will be also evaluated. The measurements will be recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

June 7, 2016

Last Update Submit

March 29, 2024

Conditions

Orthodontics

Outcome Measures

Primary Outcomes (1)

  • Speed of tooth movement

    The total duration of active orthodontic treatment will be estimated in weeks from the time of starting the active orthodontic treatment, immediately following the corticotomy procedure, to the time of debonding.

    Baseline (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).

Secondary Outcomes (2)

  • Bone density

    Baseline (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).

  • Root length

    Baseline (T1), post-treatment at time of debonding (T2), and 9 months post-treatment (T3).

Study Arms (3)

Corticotomy alone

NO INTERVENTION

Group I will be treated with a modified technique of corticotomy assisted orthodontic treatment (CAOT) alone

Corticotomy + xenograft

EXPERIMENTAL

group II (included 6 females and 5 males) that treated with CAOT combined with bovine derived xenograft (Biogen, Biotecksrl Fermi, Arcugraro VI, Italy);

Drug: Xenograft

Corticotomy + bioactive glass

EXPERIMENTAL

group III (included 7 females and 4 males) that treated with CAOT combined with bioactive glass (Bio-Glass, Excellence Pharm Inc., Egypt).

Drug: Bioactive glass

Interventions

XenograftDRUG

group II will be treated with CAOT combined with bovine derived xenograft (Biogen, Biotecksrl Fermi, Arcugraro VI, Italy);

Also known as: bovine derived xenograft
Corticotomy + xenograft
Bioactive glassDRUG

group III will be treated with CAOT combined with bioactive glass (Bio-Glass, Excellence Pharm Inc., Egypt).

Corticotomy + bioactive glass

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A moderate 4-5mm crowding of the lower anterior teeth
  • Good oral hygiene
  • Healthy systemic condition

You may not qualify if:

  • previous orthodontic treatment
  • Probing depth values exceeding 3 mm
  • Radiographic evidence of bone loss
  • Regular administration medication that affects bone metabolism such as prolonged use of corticosteroids, or bisphosphonates and NSAIDs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdelaziz University. Faculty of dentistry

Jeddah, 21589, Saudi Arabia

Location

Related Publications (1)

  • Bahammam MA. Effectiveness of bovine-derived xenograft versus bioactive glass with periodontally accelerated osteogenic orthodontics in adults: a randomized, controlled clinical trial. BMC Oral Health. 2016 Nov 30;16(1):126. doi: 10.1186/s12903-016-0321-x.

    PMID: 27903250DERIVED

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Consultant of Periodontology

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 13, 2016

Study Start

September 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 1, 2024

Record last verified: 2024-03

Locations

SA(1)