Pain, Acceptance, and Discomfort With Periodontally Accelerated Osteogenic Orthodontics (PAOO)

Completed

• Conditions: Crowding of Anterior Mandibular Teeth
• Interventions: Procedure: Periodontally Accelerated Osteogenic Orthodontics (PAOO)

• Registration Number: NCT04728464
• Lead Sponsor: Damascus University

Brief Summary

Patients will be examined in the Orthodontic Department of the University of Damascus Dental School. Patients who will be treated in conjunction with the PAOO procedure and subjects who will meet the inclusion criteria will be included then the initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, as well as radiographic images) will be studied to ensure that the selection criteria will be accurately matched. This study aims to assess patients' acceptance of the PAOO procedure as well as the levels of pain and discomfort associated with this treatment.

Detailed Description

Surgical procedure associated with PAOO The surgery will be performed under local anesthesia and then full-thickness flaps will be reflected labially only from the distal surface of the lower right canine to the distal surface of the lower left canine, after washing the exposed alveolar bone with saline, then a selective cortical cutting will be performed using a piezosurgery and then the Bone-D® xenograft (particle size of 0.2 mm-1.0 mm) from Medpark (Busan, Korea) will be placed, then the wound will be sutured. Then a schedule will be set up to review the patient after 1, 7, 14, and 28 days to fill out questionnaires related to pain, acceptance, discomfort, satisfaction, and follow-up to orthodontic treatment.

Study Timeline

• Study Start: 2018-08-29
• Primary Completion: 2020-07-01
• Study Completion: 2020-11-01
• Status Verified: 2021-01
• Study First Submitted: 2021-01-24
• Study First Submitted QC: 2021-01-24
• Study First Posted: 2021-01-28
• Last Update Submitted: 2021-01-30
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Class I malocclusion with moderate crowding (4-6 mm of a tooth-size-arch-length-discrepancy).
2. Good oral hygiene and periodontal health.
3. No severe skeletal discrepancy.
4. Normal proclination for the upper and lower incisors.
5. No congenitally missing or extracted teeth (except for the third molars).

Exclusion Criteria

1. Bimaxillary dentoalveolar severe protrusion.
2. Previous orthodontic treatment.
3. Subject with psychological abnormalities.
4. Subject with systemic diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Periodontally Accelerated Osteogenic Orthodontics (PAOO)	Periodontally Accelerated Osteogenic Orthodontics (PAOO)	Patients will be treated by Periodontally Accelerated Osteogenic Orthodontics using fixed appliances.

Primary Outcome Measures

Name	Time	Method
Change in perception of pain	(1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks	Patients will be asked about their pain perception (item 1 of the first questionnaire).; "How much pain did you have?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS).; The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain).
Taking any type of pain killers	(1) after 4 weeks following the beginning of the treatment	Patients will be asked about taking any type of pain killers (item 3 of the second questionnaire).; "Did you take any type of pain killers during the treatment?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered. The scale is two-point (Yes, No) and the patient will select one answer yes or no.; If the patient's answer is (Yes), he is asked to specify the number of pain killers that he took during the treatment "when did you take pain killers? How many tablets as a whole?"
Change in perception of discomfort	(1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks	Patients will be asked about their discomfort (item 2 of the first questionnaire).; "How much discomfort did you have?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS).; The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no discomfort - 100: the worst discomfort).
Change in the feeling of swelling	(1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks	Patients will be asked about how much they feel swollen (item 3 of the first questionnaire).; "How much swelling did you feel?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS).; The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no swelling - 100: the worst swelling).
Change in the difficulty of mastication	(1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks	Patients will be asked about the difficulty of mastication (item 4 of the first questionnaire).; "How many difficulties in mastication did you have?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS).; The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no difficulty of mastication - 100: the worst difficulty of mastication).
Change in difficulty swallowing	(1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks]	Patients will be asked about how difficult it is to swallow (item 5 of the first questionnaire).; "How many difficulties in swallowing did you feel?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS).; The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no difficulty swallowing - 100: the worst difficulty swallowing).
Change in the limits of opening the mouth	(1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks	Patients will be asked about the limits of the mouth opening limits (item 6 of the first questionnaire).; "How much mouth limitation did you feel?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS).; The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no limitation in opening the mouth - 100: the worst limits in opening the mouth).
Change in the level of satisfaction with accelerated treatment	(1) after 4 weeks following the beginning of the treatment	Patients will be asked about satisfaction with accelerated treatment (item 1 of the second questionnaire).; "How much are you satisfied with your accelerated treatment?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS).; The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no satisfaction with accelerated treatment - 100: best satisfaction with accelerated treatment).
Recommendation for the procedure	(1) after 4 weeks following the beginning of the treatment	Patients will be asked about a friend's recommendation for this procedure (item 2 of the second questionnaire).; "Would you recommend this procedure to a friend?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered. The scale is two-point (yes, no) and the patient will select one answer yes or no.

Trial Locations

Locations (1)

Department of Orthodontics, University of Damascus Dental School; 🇸🇾 Damascus, Syrian Arab Republic