NCT05717478

Brief Summary

Aim of the present investigation will be to evaluate the efficacy and safety of a granulate of rhBMP-2- loaded bovine bone mineral (rhBMP-2-BBM) as alveolar bone regeneration procedure following tooth extraction. Forty (40) patients (both sex; age 18 years and older) requiring extraction of one (1) hopeless tooth (incisor, canine or premolar with loss of bone height of 5 mm or more in buccal alveolar wall), followed by alveolar bone regeneration (ABR) and placement of an endosteal implant will be enrolled into the study. After exodontia, participants will be randomized and divided into two groups: in Experimental Group the socket will be grafted with rhBMP-2-BBM granules (1.0-0.25 mm); in Control Group the sockets will be grafted with Bio-Oss granules (1.0-0.25 mm) and covered with porcine collagen barrier membrane (Bio-Gide). The end of the study will be fixed at the implantation surgery, seventeen (17) weeks after exodontia an ABR. Cone beam computed tomography (CBCT) scans will be made, immediately after (0), and sixteen (16) weeks after exodontia an ABR and the gain in alveolar bone height will be estimated and used as the primary outcome for comparison of both groups. As secondary efficacy outcomes the change in alveolar bone width estimated from the CBCT scans; initial (0) and at seventeenth (17th) week after tooth extraction; the change in dental arch dimensions estimated from tridimensional models obtained from intraoral scans at one week before (-1) and sixteen (16) weeks exodontia an ABR; and the amounts of new bone, remnant material and connective tissue histomorphometrically measured in a bone biopsy collected during the implantation surgery at seventeenth (17th) week, will be considered. Healing of gingival tissues at first (1st) and second (2nd) week and incidence of adverse reactions at first (1st), second (2nd) and sixteenth (16th) week, are used as secondary safety outcomes.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

April 12, 2023

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

January 28, 2023

Last Update Submit

April 11, 2023

Conditions

Loss of Teeth Due to ExtractionAlveolar Bone LossEdentulous Alveolar Ridge

Keywords

Alveolar Bone LossAlveolar Ridge AugmentationBone RegenerationBone Morphogenetic Protein 2Hydroxyapatite

Outcome Measures

Primary Outcomes (1)

  • Bone height gain after tooth extraction and socket regeneration

    Difference between alveolar bone heights measured immediately after tooth extraction and 16 weeks after. Bone heights are measured from the CBCT scans obtained in the second and fifth visits using as reference a customized splint as elsewhere (PMID: 30883942)

    16 weeks

Secondary Outcomes (6)

  • Bone width changes after tooth extraction and socket regeneration

    16 weeks

  • Dental arch dimensional changes after tooth extraction and socket regeneration

    16 weeks

  • Need for second bone augmentation after tooth extraction and socket regeneration

    17 weeks

  • Amounts of New Bone; Remnant Material and Connective Tissue after tooth extraction and socket regeneration

    17 weeks

  • Early Healing Index after tooth extraction and socket regeneration

    1 and 2 weeks

  • +1 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

Socket preservation after extraction with Proteo-Graft (Noricum S.L.) with a particle size of 0.25-1.00 mm, without using a barrier membrane.

Combination Product: rhBMP-2-BBM

Control

ACTIVE COMPARATOR

Conventional treatment (socket preservation therapy). Post-extraction socket preservation with Bio-Oss® (Geistlich Pharma AG, Switzerland) with a particle size of 0.25-1.00 mm, hereinafter BO, and protection with a barrier membrane, Bio-Gide® ( Geistlich Pharma AG, Switzerland).

Device: Bio-Oss+Bio-Gide

Interventions

rhBMP-2-BBMCOMBINATION_PRODUCT

Alveolar socket is filled with granules of bovine bone mineral (1.0-0.25 mm) loaded with human recombinant bone morphogenetic protein 2

Experimental
Bio-Oss+Bio-GideDEVICE

Alveolar socket is filled with granules of bovine bone mineral (Bio-Oss 1.0-0.25 mm) and covered with porcine collagen barrier membrane (Bio-Gide)

Control

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy patients with one tooth to be extracted, from incisor to premolar, and with buccal bone wall loss of 5 mm or more
  • Plaque index lower than 30%
  • Eighteen (18) years old and elder.
  • Willing to participate and written informed consent

You may not qualify if:

  • Heavy smokers (more than 20 cigarettes per day)
  • Plaque index greater than 30 %
  • Pathologies hindering interventions or influencing healing or host response
  • Inability to comply scheduled follow-up
  • Comprehension disability that compromises informed consent and compliance with medical instructions
  • Receptor of any other experimental treatments, actual or in past 30 days
  • Current pregnant patients or planning to get pregnant in short term
  • Breastfeeding mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Universidad Complutense de Madrid

Madrid, 28040, Spain

RECRUITING

Related Publications (5)

  • Wachtel H, Schenk G, Bohm S, Weng D, Zuhr O, Hurzeler MB. Microsurgical access flap and enamel matrix derivative for the treatment of periodontal intrabony defects: a controlled clinical study. J Clin Periodontol. 2003 Jun;30(6):496-504. doi: 10.1034/j.1600-051x.2003.00013.x.

    PMID: 12795787BACKGROUND

  • Jo DW, Cho YD, Seol YJ, Lee YM, Lee HJ, Kim YK. A randomized controlled clinical trial evaluating efficacy and adverse events of different types of recombinant human bone morphogenetic protein-2 delivery systems for alveolar ridge preservation. Clin Oral Implants Res. 2019 May;30(5):396-409. doi: 10.1111/clr.13423. Epub 2019 Apr 11.

    PMID: 30883942BACKGROUND

  • Sanz-Martin I, Encalada C, Sanz-Sanchez I, Aracil J, Sanz M. Soft tissue augmentation at immediate implants using a novel xenogeneic collagen matrix in conjunction with immediate provisional restorations: A prospective case series. Clin Implant Dent Relat Res. 2019 Feb;21(1):145-153. doi: 10.1111/cid.12696. Epub 2018 Dec 3.

    PMID: 30508313BACKGROUND

  • Donath K, Breuner G. A method for the study of undecalcified bones and teeth with attached soft tissues. The Sage-Schliff (sawing and grinding) technique. J Oral Pathol. 1982 Aug;11(4):318-26. doi: 10.1111/j.1600-0714.1982.tb00172.x.

    PMID: 6809919BACKGROUND

  • Ortiz-Vigon A, Martinez-Villa S, Suarez I, Vignoletti F, Sanz M. Histomorphometric and immunohistochemical evaluation of collagen containing xenogeneic bone blocks used for lateral bone augmentation in staged implant placement. Int J Implant Dent. 2017 Dec;3(1):24. doi: 10.1186/s40729-017-0087-1. Epub 2017 Jun 21.

    PMID: 28634845BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Mariano Sanz, MD,PHD

    Universidad Complutense de Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Sanz-Esporrin, PhD

CONTACT

913941920javier.sanz.esporrin@ucm.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective and superiority therapeutic study with participants randomly distributed in two arms of equal size, one arm to receive Experimental treatment and the other Control treatment and blinded to participants and outcomes assessors.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2023

First Posted

February 8, 2023

Study Start

November 15, 2022

Primary Completion

September 15, 2024

Study Completion

September 15, 2024

Last Updated

April 12, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)