NCT04955873

Brief Summary

This pilot multicentric randomized controlled clinical trial is aimed at evaluating the composition of the new-formed tissue into the dental socket after 6 months from tooth extraction and the application of a combination of xenograft bone granules and collagen membrane. Extraction sites will be either grafted with Dentsply Symbios Xenograft Granules and covered with Dentsply Symbios pre-hydrated Collagen Resorbable Membrane or grafted with Geistlich Bio-Oss Collagen and covered with Geistlich Bio-Gide membrane. Results will be compared to spontaneous socket healing.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

August 10, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

July 5, 2021

Last Update Submit

August 3, 2021

Conditions

Alveolar Bone ResorptionEdentulous Alveolar Ridge

Keywords

Ridge preservationXenograftCollagen membraneSocket preservationSocket managementBiomaterialHistomorphometry

Outcome Measures

Primary Outcomes (2)

  • Composition of new-formed hard tissue into the post-extractive socket

    Amount of mineralized bone, residual biomaterial, fibrous tissue

    Six months after surgery

  • Composition of new-formed soft tissue over the post-extractive socket

    Amount of epithelial tissue, connective tissue, of neovascularization, inflammatory cells, residual collagenic biomaterial

    Six months after surgery

Secondary Outcomes (2)

  • Implant torque at insertion

    Six months after surgery, at implant insertion.

  • Width of keratinized mucosa

    Six months after surgery, at implant insertion.

Study Arms (3)

Test - Group A - Dentsply biomaterials

EXPERIMENTAL

Dental extraction socket treated with the combined use of the xenogenic bone granules "Dentsply Sirona Symbios Xenograft Granules" and the resorbable collagen membrane "Dentsply Sirona Symbios Collagen Membrane SR".

Device: Treatment of the dental extraction socket using newly-released biomaterials

Active comparator - Group B - Geistlich biomaterials

ACTIVE COMPARATOR

Dental extraction socket treated with the combined use of the xenogenic bone granules "Geistlich Bio-oss Collagen" and the resorbable collagen membrane "Geistlich BioGide".

Device: Treatment of the dental extraction socket using well-known biomaterials

Control - Group C - Spontaneous healing

NO INTERVENTION

Spontaneous postextraction alveolar healing

Interventions

Treatment of the dental extraction socket using newly-released biomaterialsDEVICE

Treatment of the dental extraction socket with the combined use with the combined use of a newly-released xenogenic bone granules and a resorbable collagen membrane.

Test - Group A - Dentsply biomaterials
Treatment of the dental extraction socket using well-known biomaterialsDEVICE

Treatment of the dental extraction socket with the combined use of a well-known xenogenic bone granules and a resorbable collagen membrane

Active comparator - Group B - Geistlich biomaterials

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have at least one tooth (from the central incisor to the second permanent molar) to be extracted and replaced with an endosseous implant;
  • no need of a temporary prosthesis;
  • availability to participate to the follow-up;
  • sign the study informed consent and consent to data treatment;

You may not qualify if:

  • less than 20 years;
  • known allergy to collagen or bone graft material;
  • contraindications to implant therapy;
  • ongoing bisphosphonate-based therapy;
  • ongoing high-dose corticosteroid therapy;
  • relevant co-morbidities of the maxillary bones that interfere with bone remodeling (degenerative bone diseases, osteomyelitis at the extraction site or surrounding areas, subacute mandibular osteitis, local microvascular disorders);
  • smoking;
  • pregnancy;
  • metabolic diseases (diabetes, hyperparathyroidism);
  • systemic bone diseases;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Studio Odontoiatrico Maia Dentis

Merano, Bolzano, 39012, Italy

RECRUITING

Studio Medico Dentistico Dott. Mandelli

Pioltello, Milano, 20096, Italy

RECRUITING

Studio Dentistico Bressan Associati Di Bressan Eriberto - Bressan Giuseppe - Bressan Paolo

Chions, Pordenone, 33083, Italy

RECRUITING

Studio Dentistico Associato Tomasi-Ghensi-Varotto

Cembra, Trento, 38054, Italy

ENROLLING BY INVITATION

Studio Dentistico Donati Di Donati Andrea & Mauro

Perugia, 06121, Italy

RECRUITING

Related Publications (3)

  • Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057. Erratum In: J Clin Periodontol. 2020 Jan;47(1):129. doi: 10.1111/jcpe.13212.

    PMID: 30623987BACKGROUND

  • Lindhe J, Cecchinato D, Donati M, Tomasi C, Liljenberg B. Ridge preservation with the use of deproteinized bovine bone mineral. Clin Oral Implants Res. 2014 Jul;25(7):786-90. doi: 10.1111/clr.12170. Epub 2013 Apr 4.

    PMID: 23556467BACKGROUND

  • Tomasi C, Tessarolo F, Caola I, Piccoli F, Wennstrom JL, Nollo G, Berglundh T. Early healing of peri-implant mucosa in man. J Clin Periodontol. 2016 Oct;43(10):816-24. doi: 10.1111/jcpe.12591. Epub 2016 Jul 28.

    PMID: 27329966BACKGROUND

Study Officials

  • Francesco Tessarolo, PhD

    Bruno Kessler Fundation, Trento Italy

    PRINCIPAL INVESTIGATOR

  • Paolo Ghensi, DDS, PhD

    Università degli Studi di Trento

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Ghensi, DDS, PhD

CONTACT

+39 0461 282775dr.ghensi@gmail.com

Francesco Tessarolo, PhD

CONTACT

+39 0461 282775francesco.tessarolo@unitn.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 9, 2021

Study Start

August 1, 2021

Primary Completion

February 1, 2023

Study Completion

April 1, 2023

Last Updated

August 10, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(5)