Clinical trial NCT04728464: Pain, Acceptance, and Discomfort With Periodontally Accelerated Osteogenic Orthodontics (PAOO)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crowding of Anterior Mandibular Teeth
Keywords: Visual Analog Scale
Acceleration
moderate crowding
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in perception of pain
timeFrame: (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
measure: Change in perception of discomfort
timeFrame: (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
measure: Change in the feeling of swelling
timeFrame: (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
measure: Change in the difficulty of mastication
timeFrame: (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
measure: Change in difficulty swallowing
timeFrame: (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]
measure: Change in the limits of opening the mouth
timeFrame: (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
measure: Change in the level of satisfaction with accelerated treatment
timeFrame: (1) after 4 weeks following the beginning of the treatment
measure: Recommendation for the procedure
timeFrame: (1) after 4 weeks following the beginning of the treatment
measure: Taking any type of pain killers
timeFrame: (1) after 4 weeks following the beginning of the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Orthodontics, University of Damascus Dental School
Study officials:
affiliation: MSc student at the Orthodontic Department, University of Damascus Dental
name: Hallaj I Alsino, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
name: Mohammad Y Hajeer, DDS,MSc,PhD
role: STUDY_CHAIR
affiliation: Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, Syria
name: Issam Khoury, DDS,MSc,PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.