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

NCT ID: NCT04728464

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-29

Study Completion Date

2020-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crowding of Anterior Mandibular Teeth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Periodontally Accelerated Osteogenic Orthodontics (PAOO)

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

Periodontally Accelerated Osteogenic Orthodontics (PAOO)

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Damascus University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hallaj I Alsino, DDS

Role: PRINCIPAL_INVESTIGATOR

MSc student at the Orthodontic Department, University of Damascus Dental

Mohammad Y Hajeer, DDS,MSc,PhD

Role: STUDY_CHAIR

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

Issam Khoury, DDS,MSc,PhD

Role: STUDY_DIRECTOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Orthodontics, University of Damascus Dental School

Damascus, , Syria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Syria

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25478442 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31143007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23210199 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30991984 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11829041 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UDDS-Ortho-01-2021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.