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

Evaluation of the Levels of Pain and Discomfort of 'Periodontally Accelerated Osteogenic Orthodontics' (PAOO) in the Leveling and Alignment of Crowded Lower Anterior Teeth: A Prospective Non-controlled Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Crowding of Anterior Mandibular Teeth
• Intervention / Treatment: Procedure: Periodontally Accelerated Osteogenic Orthodontics (PAOO)

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 Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic
    • Department of Orthodontics, University of Damascus Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 28 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with malocclusion

1. Crowding on the lower arch with a moderate degree (i.e., between 4 to six millimeters of a tooth-size-arch-length discrepancy).
2. Class I malocclusion
3. With no severe skeletal discrepancy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Periodontally Accelerated Osteogenic Orthodontics (PAOO); Patients will be treated by Periodontally Accelerated Osteogenic Orthodontics using fixed appliances.	Procedure: Periodontally Accelerated Osteogenic Orthodontics (PAOO); Fixed appliance will be placed for every patient, then surgical procedure will be applied after reflecting a full-thickness labial flap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perception of pain	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).	(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
Change in perception of discomfort	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).	(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
Change in the feeling of swelling	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).	(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
Change in the difficulty of mastication	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).	(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
Change in difficulty swallowing	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).	(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]
Change in the limits of opening the mouth	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).	(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
Change in the level of satisfaction with accelerated 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).	(1) after 4 weeks following the beginning of the treatment
Recommendation for the procedure	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.	(1) after 4 weeks following the beginning of the treatment
Taking any type of pain killers	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?"	(1) after 4 weeks following the beginning of the treatment

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Study Director: Issam Khoury, DDS,MSc,PhD, Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, SYRIA; Principal Investigator: Hallaj I Alsino, DDS, MSc student at the Orthodontic Department, University of Damascus Dental

Publications and helpful links

General Publications

• Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.
• Bhattacharya P, Bhattacharya H, Anjum A, Bhandari R, Agarwal DK, Gupta A, Ansar J. Assessment of Corticotomy Facilitated Tooth Movement and Changes in Alveolar Bone Thickness - A CT Scan Study. J Clin Diagn Res. 2014 Oct;8(10):ZC26-30. doi: 10.7860/JCDR/2014/9448.4954. Epub 2014 Oct 20.
• Chandra RV, Rachala MR, Madhavi K, Kambalyal P, Reddy AA, Ali MH. Periodontally accelerated osteogenic orthodontics combined with recombinant human bone morphogenetic protein-2: An outcome assessment. J Indian Soc Periodontol. 2019 May-Jun;23(3):257-263. doi: 10.4103/jisp.jisp_612_18.
• Shoreibah EA, Ibrahim SA, Attia MS, Diab MM. Clinical and radiographic evaluation of bone grafting in corticotomy-facilitated orthodontics in adults. J Int Acad Periodontol. 2012 Oct;14(4):105-13.
• Wilcko WM, Wilcko T, Bouquot JE, Ferguson DJ. Rapid orthodontics with alveolar reshaping: two case reports of decrowding. Int J Periodontics Restorative Dent. 2001 Feb;21(1):9-19.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 29, 2018
• Primary Completion (ACTUAL): July 1, 2020
• Study Completion (ACTUAL): November 1, 2020

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: January 24, 2021
• First Posted (ACTUAL): January 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 30, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Visual Analog Scale; moderate crowding; Acceleration
• Other Study ID Numbers: UDDS-Ortho-01-2021

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