Effect on the Periodontal Phenotype of Flapless Alveolar Decortication and Augmentation During Orthodontic Treatment: A Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Research Question While the reduction in treatment times and the patient satisfaction after periodontally accelerated osteogenic orthodontics (PAOO) are well sustained in the scientific literature, there is still controversy regarding if grafting leads to i) change of the periodontal phenotype and ii) greater stability of post-orthodontic treatment outcomes, highlighting the need of controlled clinical trials. Aims of the Project The aim of this randomized clinical trial (RCT) is to compare piezocision-assisted orthodontics, concomitant to soft tissue grafting (volume-stable collagen matrix), with piezocision-assisted orthodontics, concomitant to bone grafting with a xenograft and a native collagen membrane, in orthodontic non-growing patients. The primary aim will be to determine the impact of this surgical protocol on the hard and soft tissue changes occurring on the buccal aspect of the dentition. Secondary objectives will include the assessment of the comparative impact on treatment duration, rate of tooth movements, presence of root resorption, periodontal parameters, bone level changes and patient-reported outcome measures (PROMs) between the two groups.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 70
Healthy Volunteers: f
View:

⁃ Patients will be consecutively selected among those attending the Faculty of Odontology, University Complutense (Madrid, Spain) looking for orthodontic therapy.

⁃ The inclusion criteria will be as follows:

• patients requiring maxillary and/or mandible orthodontic treatment;

• patients with permanent dentition in stage 5 or 6 of the cervical vertebral maturation method as described by Baccetti et al. (2002);

• minimal to moderate maxillary and/or mandibular anterior crowding at baseline (arch length discrepancy from 3-8 mm); and

• adequate oral health (i.e. periodontal health, absence of periapical infections and untreated caries).

Locations
Other Locations
Spain
Faculty of Odontology, University Complutense Madrid
RECRUITING
Madrid
Contact Information
Primary
Eduardo Montero, Prof
eduardomonterosolis@ucm.es
+34 91 3941901
Backup
Conchita Martin, Prof
mariacom@ucm.es
+34 91 3941923
Time Frame
Start Date: 2024-04
Estimated Completion Date: 2025-04
Participants
Target number of participants: 40
Treatments
Experimental: Collagen matrix
a cross-linked volume stable collagen matrix (VCMX; Geistlich Fibro-Gide, Geistlich Pharma AG)
Active_comparator: Xenograft
a graft consisting of bovine hydroxyapatite xenograft (Geistlich Bio-Oss; Geistlich Pharma AG), covered by a native collagen membrane (Geistlich Bio-Gide; Geistlich Pharma AG), tagged with pins at the ends.
Related Therapeutic Areas
Sponsors
Collaborators: Osteology Foundation
Leads: Universidad Complutense de Madrid

This content was sourced from clinicaltrials.gov