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NCT Number: NCT05390320

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

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.

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Key information

Conditions

Crowding, Tooth Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

18 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Damascus

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

PAOO

Procedure

Periodontally accelerated osteogenic orthodontics will be applied to treat patients with moderate crowding.

Fixed appliance

Other

Fixed appliances will be applied to treat patients with moderate crowding without any acceleration methods.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 25, 2022
Registry last updated
May 25, 2022

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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