search
Back to results

Ridge Preservation Using Xenogenic Bone Graft and Pre-hydrated Collagen Membrane

Primary Purpose

Alveolar Bone Resorption, Edentulous Alveolar Ridge

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Treatment of the dental extraction socket using newly-released biomaterials
Treatment of the dental extraction socket using well-known biomaterials
Sponsored by
Fondazione Bruno Kessler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Resorption focused on measuring Ridge preservation, Xenograft, Collagen membrane, Socket preservation, Socket management, Biomaterial, Histomorphometry

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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;

Sites / Locations

  • Studio Odontoiatrico Maia DentisRecruiting
  • Studio Medico Dentistico Dott. MandelliRecruiting
  • Studio Dentistico Bressan Associati Di Bressan Eriberto - Bressan Giuseppe - Bressan PaoloRecruiting
  • Studio Dentistico Associato Tomasi-Ghensi-Varotto
  • Studio Dentistico Donati Di Donati Andrea & MauroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Test - Group A - Dentsply biomaterials

Active comparator - Group B - Geistlich biomaterials

Control - Group C - Spontaneous healing

Arm Description

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".

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

Spontaneous postextraction alveolar healing

Outcomes

Primary Outcome Measures

Composition of new-formed hard tissue into the post-extractive socket
Amount of mineralized bone, residual biomaterial, fibrous tissue
Composition of new-formed soft tissue over the post-extractive socket
Amount of epithelial tissue, connective tissue, of neovascularization, inflammatory cells, residual collagenic biomaterial

Secondary Outcome Measures

Implant torque at insertion
Dynamometric measurement of the insertion torque at implant placement
Width of keratinized mucosa
Extension of keratinized mucosa in the bucco-lingual direction

Full Information

First Posted
July 5, 2021
Last Updated
August 3, 2021
Sponsor
Fondazione Bruno Kessler
Collaborators
Dentsply Sirona Implants and Consumables
search

1. Study Identification

Unique Protocol Identification Number
NCT04955873
Brief Title
Ridge Preservation Using Xenogenic Bone Graft and Pre-hydrated Collagen Membrane
Official Title
Ridge Preservation With the Use of a Xenogenic Bone Graft Material (Symbios Xenograft Granules) and a Pre-hydrated Collagen Membrane Symbios Pre-hydrated Collagen Resorbable Membrane): A Pilot Multicenter Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Bruno Kessler
Collaborators
Dentsply Sirona Implants and Consumables

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Rational Socket preservation techniques are effective in mitigating the dimensional changes of the alveolar socket that spontaneously occur after tooth extraction (Avila-Ortiz G, et al. 2019). However, there is insufficient information regarding the type and quality of the newly formed tissue at the extraction site before implant positioning. Study design This study is a three-arm multicentric randomized trial that will evaluate the bone healing following ridge preservation of extraction sockets using two different combinations of commercially available xenograft bone granules and collagen membranes available in the market. Results will be compared to tissues obtained from spontaneous healing. A total of 45 participants (15 in each arm) is expected. Study protocol Patients, satisfying inclusion criteria and having signed study informed consent, will be randomly allocated to three study groups, receiving the following treatments at the time of tooth extraction: Group A: grafting of postextraction socket with Dentsply Symbios Xenograft granules covered with Dentsply Symbios pre-hydrated Collagen Resorbable Membrane (Test - Group A) Group B: grafting of postextraction socket with Geistlich Bio-Oss Collagen and covering with Geistlich Bio-Gide Collagen membrane (Active comparator - Group B) Group C: no further treatment of the postextraction socket (spontaneous healing, Control - Group C) After 6 months from the extraction, radiographic examinations will be performed and the implant surgery will take place. On the day of the surgery the width of keratinized mucosa at socked site will be registered. Then, following loco-regional anesthesia, a soft tissue sample of 3 mm in diameter will be obtained using a circular punch at the site intended to receive the implant. Subsequently, a flap will be elevated. Using a trephine drill a 3 mm in diameter block of hard tissue with a length of 5- 6 mm will be collected. The preparation of the implant site will be then carried out until the desired diameter and length are reached for the insertion of the corresponding implant. Torque at implant insertion will be registered. Once the implant has been inserted, the healing abutment will be positioned and soft tissues will be sutured with single sutures. The prosthetic rehabilitation will be completed after osseointegration, approximately 3 months after the implant surgery. Histological analysis of soft tissue and hard tissue biopsies Tissue samples will be immediately fixed in formalin after collection. Histological analysis will be performed on formalin-fixed paraffin-embedded tissue sections, to determine the quantity and quality newly formed tissue and the remaining fraction of the implanted biomaterials. More specifically, the collected tissue biopsies will be fixed in 4% buffered formalin, decalcified into ethylenediaminetetraacetic acid (EDTA) (if necessary), dehydrated and included in paraffin. Serial sections, including the central portion of the biopsy, will be prepared and colored in hematoxylin and eosin. Vascular structures will be identified by CD34 (Cluster of differentiation 34, hematopoietic progenitor cell antigen) antibody. Portions occupied by mineralized bone (lamellar bone, trabecular bone), osteoid (partially mineralized connective tissue matrix rich in collagen), bone marrow (adipocytes and vascular structures), fibrous tissue (unorganized collagen fibers, cells and vessels), biomaterial granules and residual tissue (unidentified tissue elements, preparation artifacts) will be characterized by morphometric measurements performed according to the protocol described by Lindhe et al. (Clin. Oral Impl. Res.2014;25:786-790). Soft tissues characterization will include the analysis of the structural composition of epithelial and connective tissues, the quantification of the amount micro-vessels in connective tissue, the definition of the inflammatory cell types, and the collagen tissue content according to protocols described in Tomasi et al. (J Clin Periodontol. 2016;43:816-24). Data analysis and statistics Data analysis will be aimed at detecting statistically significant differences in tissue composition between the group A in respect to the most appropriate of the two remaining groups (e.g. the percentage of bone tissue in the test group will be compared with that of control group C while the percentage of residual biomaterial six months after implantation will be compared with the active control B). Statistically significant differences with p<0.05 will be considered. Data normality will be verified with the Shapiro-Wilk test. Outcome variables for each of three groups will be expressed by means of mean ± standard deviation for continuous variables with normal distribution, or by means of median and value at the 25th and 75th percentile for variables with non-normal distribution. Parametric or non-parametric statistical tests will then be applied to compare between groups, according to data normality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Resorption, Edentulous Alveolar Ridge
Keywords
Ridge preservation, Xenograft, Collagen membrane, Socket preservation, Socket management, Biomaterial, Histomorphometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test - Group A - Dentsply biomaterials
Arm Type
Experimental
Arm Description
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".
Arm Title
Active comparator - Group B - Geistlich biomaterials
Arm Type
Active Comparator
Arm Description
Dental extraction socket treated with the combined use of the xenogenic bone granules "Geistlich Bio-oss Collagen" and the resorbable collagen membrane "Geistlich BioGide".
Arm Title
Control - Group C - Spontaneous healing
Arm Type
No Intervention
Arm Description
Spontaneous postextraction alveolar healing
Intervention Type
Device
Intervention Name(s)
Treatment of the dental extraction socket using newly-released biomaterials
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Treatment of the dental extraction socket using well-known biomaterials
Intervention Description
Treatment of the dental extraction socket with the combined use of a well-known xenogenic bone granules and a resorbable collagen membrane
Primary Outcome Measure Information:
Title
Composition of new-formed hard tissue into the post-extractive socket
Description
Amount of mineralized bone, residual biomaterial, fibrous tissue
Time Frame
Six months after surgery
Title
Composition of new-formed soft tissue over the post-extractive socket
Description
Amount of epithelial tissue, connective tissue, of neovascularization, inflammatory cells, residual collagenic biomaterial
Time Frame
Six months after surgery
Secondary Outcome Measure Information:
Title
Implant torque at insertion
Description
Dynamometric measurement of the insertion torque at implant placement
Time Frame
Six months after surgery, at implant insertion.
Title
Width of keratinized mucosa
Description
Extension of keratinized mucosa in the bucco-lingual direction
Time Frame
Six months after surgery, at implant insertion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paolo Ghensi, DDS, PhD
Phone
+39 0461 282775
Email
dr.ghensi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Tessarolo, PhD
Phone
+39 0461 282775
Email
francesco.tessarolo@unitn.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Tessarolo, PhD
Organizational Affiliation
Bruno Kessler Fundation, Trento Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paolo Ghensi, DDS, PhD
Organizational Affiliation
Università degli Studi di Trento
Official's Role
Principal Investigator
Facility Information:
Facility Name
Studio Odontoiatrico Maia Dentis
City
Merano
State/Province
Bolzano
ZIP/Postal Code
39012
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Bonaccorso, MD
First Name & Middle Initial & Last Name & Degree
Teresa R Tripi, MD
Facility Name
Studio Medico Dentistico Dott. Mandelli
City
Pioltello
State/Province
Milano
ZIP/Postal Code
20096
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Federico Mandelli, MD
Facility Name
Studio Dentistico Bressan Associati Di Bressan Eriberto - Bressan Giuseppe - Bressan Paolo
City
Chions
State/Province
Pordenone
ZIP/Postal Code
33083
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eriberto Bressan, MD, Prof.
Facility Name
Studio Dentistico Associato Tomasi-Ghensi-Varotto
City
Cembra
State/Province
Trento
ZIP/Postal Code
38054
Country
Italy
Individual Site Status
Enrolling by invitation
Facility Name
Studio Dentistico Donati Di Donati Andrea & Mauro
City
Perugia
ZIP/Postal Code
06121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mauro Donati

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30623987
Citation
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.
Results Reference
background
PubMed Identifier
23556467
Citation
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.
Results Reference
background
PubMed Identifier
27329966
Citation
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.
Results Reference
background

Learn more about this trial

Ridge Preservation Using Xenogenic Bone Graft and Pre-hydrated Collagen Membrane

We'll reach out to this number within 24 hrs