Dental and Periodontal Changes Following the Acceleration of Alignment of Crowded Lower Anterior Teeth Using a Surgical Technique

May 20, 2022 updated by: Damascus University

Dental and Periodontal Changes Following the Acceleration of Decrowding of Lower Anterior Teeth Using a PAOO Procedure: A Randomized Controlled Trial

Patients at the Orthodontic Department of the University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be included. Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, and radiographic images) will be studied to ensure that the selection criteria are accurately matched.

This study aims to compare two groups of patients with moderate crowding of the lower anterior teeth. Experimental group: the patients in this group will be treated with periodontally accelerated osteogenic orthodontics Control group: the patients in this group will be treated using fixed appliances without any acceleration method.

Study Overview

Status

Completed

Conditions

Detailed Description

Correction of irregular teeth can take a long time, and this depends on various factors such as the good compliance of the patient, the amount of dental crowding, and the need for extraction in the course of orthodontic treatment.

Many methods have been used to accelerate tooth movement, and recently the PAOO technique has emerged as an effective therapeutic intervention.

PAOO is a promising procedure but only a few cases were reported in the literature. Controlled clinical and histological studies are needed to understand the biology of tooth movement with this procedure, the effect on teeth and bone, post-retention stability, measuring the volume of mature bone formation, and determining the status of the periodontium and roots after treatment.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 28 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • skeletal class I malocclusion (ANB=2-4)
  • normal vertical growth pattern.
  • moderate crowding of lower anterior teeth (i.e., 4-6 millimeters of a tooth size-arch length discrepancy)
  • 1 to 3 mm of overjet and 1 to 4 mm of the overbite
  • good oral health

Exclusion Criteria:

  • medical, social, and psycho contraindications to oral surgery
  • presence of periodontal diseases
  • poor oral hygiene
  • previous orthodontic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Periodontally accelerated osteogenic orthodontics
The patients in this group will be treated by periodontally accelerated osteogenic orthodontics using fixed appliances.
Periodontally accelerated osteogenic orthodontics will be applied to treat patients with moderate crowding.
Active Comparator: Conventional treatment
The patients in this group will be treated using fixed appliances and conventional treatment without any surgical intervention to accelerate tooth movement.
Fixed appliances will be applied to treat patients with moderate crowding without any acceleration methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Little's Index of Irregularity
Time Frame: T0: one day before the beginning of treatment; T1: after 1 month; T2: after 2 months; T3: after 4 months; T4: after 5 months; T5: at the end of the alignment stage which is expected within 5 - 6 months

The irregularity of the lower incisors is calculated by measuring the amount of deviations of the anatomic contact points between the six anterior teeth in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975).

The ordinary orthodontic treatment aims to keep this Index less than 1 mm at the end of treatment.

T0: one day before the beginning of treatment; T1: after 1 month; T2: after 2 months; T3: after 4 months; T4: after 5 months; T5: at the end of the alignment stage which is expected within 5 - 6 months
Change in the inter-canine width
Time Frame: T0: One day before the beginning of treatment; T1: at the end of the alignment stage
The distance between the cusp tips of the lower canines. This variable will be measured on plaster models.
T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Change in the inter-2nd premolar width
Time Frame: T0: One day before the beginning of treatment; T1: at the end of the alignment stage
The distance between the central fossae of the lower second premolars. This variable will be measured on plaster models.
T0: One day before the beginning of treatment; T1: at the end of the alignment stage

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Gingival index
Time Frame: T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Measured by degrees at each tooth: (0) Normal gingival; (1) mild inflammation; (2) Moderate inflammation; (3) severe inflammation
T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Change in the Plaque index
Time Frame: T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Measured by degrees at each tooth: (0) No plaque; (1) thin plaque layer; (2) moderate plaque layer; (3) severe plaque along the gingival margin
T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Change in the Papillary Bleeding Index
Time Frame: T0: One day before the beginning of treatment; T1: at the end of the alignment stage
Measured by the severity of any bleeding: (0) No bleeding; (1) a single discreet bleeding point; (2) several isolated bleeding points; (3) the interdental triangle fills with blood shortly after probing; (4) profuse bleeding occurs after probing.
T0: One day before the beginning of treatment; T1: at the end of the alignment stage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hallaj I Alsino, DDS, Department of orthodontics, Damascus University, Syria
  • Study Director: Issam Khoury, DDS,MSc,PhD, Department of Oral and Maxillofacial Surgery, Damascus University, Syria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

October 6, 2021

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

May 20, 2022

First Submitted That Met QC Criteria

May 20, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Ortho-10-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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