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Evaluation of the Implantation of a biomaterial in the form of a Biocellulose with Strontium Apatite membrane for preservation of the dental supporting bone margin: a randomized, double-masked study with patients

Evaluation of a biocellulose with Strontium Apatite membrane for alveolar bone crestal preservation: a randomized, double-blind clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2gfrq29
Enrollment
Unknown
Registered
2025-06-30
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar bone loss

Interventions

This is a randomized, controlled, three-arm, double-blind clinical study. Randomization will occur by randomly assigning participants, without distinction of sex or race, to one of three groups. There
D01.146.360.050
G16.762.150.150
D09.698.365.180.200

Sponsors

Universidade Estadual Vale do Acaraú
Lead Sponsor
Universidade Federal do Ceará
Collaborator

Eligibility

Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Spontaneous demand; screening between April and December 2025; signing of the free and informed consent form (FICF); adults between 20 and 40 years old; both sexes; all ethnicities; good systemic health; good oral hygiene; indication for premolar extraction due to trauma, endodontic complication or irreparable caries

Exclusion criteria

Exclusion criteria: Uncompensated diseases (hypertension, diabetes or coagulation disorder); pregnant and lactating women; smokers; irradiated; immunocompromised; users of antimicrobials or anti-inflammatories one month before the study; allergy to biomaterials or anesthetics; periapical lesions; need for ostectomy to complete the extraction; dehiscence or fenestrations observed during surgery; uncooperative patient during treatment or who does not return for reassessment (study withdrawal)

Design outcomes

Primary

MeasureTime frame
The primary outcomes will be the dimensional changes of the dental alveolus in width and height at baseline, immediately after surgery and after six months of alveolar repair.

Secondary

MeasureTime frame
Secondary outcomes will include assessment of bone density, keratinized gingival changes, overall soft tissue healing, visual assessment of pain, and quality of life, after surgery and after six months of alveolar repair.

Countries

Brazil

Contacts

Public ContactIgor Iuco Silva

Universidade Federal do Ceará

igor.iuco@sobral.ufc.br+55 (88) 99837-3015

Outcome results

None listed

Source: REBEC (via WHO ICTRP)