Using Platelet Rich Plasma in Reducing Alveolar Bone Resorption During Rapid Maxillary Expansion

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03028038
• Date of registration: 18/01/2017
• Prospective Registration: No
• Primary sponsor: Damascus University
• Public title: Using Platelet Rich Plasma in Reducing Alveolar Bone Resorption During Rapid Maxillary Expansion
• Scientific title: Evaluation of Efficacy of Injectable Platelet-Rich Plasma (PRP) in Reducing Alveolar Bone Resorption Following Rapid Maxillary Expansion (RME): A Cone Beam Computed Tomography (CBCT) Assessment
• Date of first enrolment: July 2016
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03028038
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Syrian Arab Republic

Contacts

• Name: Kinda Sultan, MSc, PhD
• Affiliation: Damascus University

Key inclusion & exclusion criteria

Inclusion Criteria:

- 10-16 years old patients

- Complete emergence of first molars and first premolars

- Clinical maxillary transverse deficiency

- Good oral hygiene (Gingival index <1) according to Silness & loe 1964

- ( Plaque index <1)

Exclusion Criteria:

- The presence of a medical situations that affects orthodontic treatment and
periodontal health

- The presence of drug therapy affect orthodontic treatment and periodontal health

- Bad oral hygiene (gingival and plaque index >1)

- Patient with physical and psychological limitations

- Metallic restorations or endodontic treatments on the appliance supporting teeth
(first molars and first premolars)

- Craniofacial anomalies

- Previous orthodontic treatment

- Patients who did not correctly follow the protocol of activation

- Patients who did not return for control dental appointments

- Patients whose cementation of the appliance failed

- Patients whose dental structures were difficult to visualize on the CBCT scans as a
result of artifact



Age minimum: 10 Years
Age maximum: 16 Years
Gender: All

Health Condition(s) or Problem(s) studied

Bone Resorption

Intervention(s)

Drug: Platelet Rich Plasma

Drug: No Platelet Rich Plasma

Primary Outcome(s)

Changes in buccal alveolar bone height loss and thickness reduction amount [Time Frame: Evaluation before and after RME. (after 3 months)]

Secondary Outcome(s)

Changes in the appliance supporting teeth inclination [Time Frame: Evaluation before and after RME. (after 3 months)]

Pain levels [Time Frame: 3 months]

Patient acceptance [Time Frame: 3 months]

Secondary ID(s)

UDDS-Ortho-04-2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors