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

NCT04728464 | Completed DMC

• 1 other identifier: UDDS-Ortho-01-2021
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Crowding of Anterior Mandibular Teeth

Keywords

Visual Analog Scale; Acceleration; moderate crowding

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

Periodontally Accelerated Osteogenic Orthodontics (PAOO)

Patients will be treated by Periodontally Accelerated Osteogenic Orthodontics using fixed appliances.

Procedure: Periodontally Accelerated Osteogenic Orthodontics (PAOO)

Interventions

Periodontally Accelerated Osteogenic Orthodontics (PAOO) PROCEDURE

Fixed appliance will be placed for every patient, then surgical procedure will be applied after reflecting a full-thickness labial flap.

Periodontally Accelerated Osteogenic Orthodontics (PAOO)

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Bimaxillary dentoalveolar severe protrusion.
• Previous orthodontic treatment.
• Subject with psychological abnormalities.
• Subject with systemic diseases.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, Syria

Location

Related Publications (5)

• 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.

  PMID: 25478442 BACKGROUND

• 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.

  PMID: 31143007 BACKGROUND

• 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.

  PMID: 23210199 BACKGROUND

• 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.

  PMID: 30991984 BACKGROUND

• 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.

  PMID: 11829041 BACKGROUND

Study Officials

• Hallaj I Alsino, DDS

  MSc student at the Orthodontic Department, University of Damascus Dental

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer, DDS,MSc,PhD

  Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

  STUDY CHAIR

• Issam Khoury, DDS,MSc,PhD

  Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, Syria

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: January 28, 2021
• Study Start: August 29, 2018
• Primary Completion: July 1, 2020
• Study Completion: November 1, 2020
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)