- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04955873
Ridge Preservation Using Xenogenic Bone Graft and Pre-hydrated Collagen Membrane
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 Overview
Status
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paolo Ghensi, DDS, PhD
- Phone Number: +39 0461 282775
- Email: dr.ghensi@gmail.com
Study Contact Backup
- Name: Francesco Tessarolo, PhD
- Phone Number: +39 0461 282775
- Email: francesco.tessarolo@unitn.it
Study Locations
-
-
-
Perugia, Italy, 06121
- Recruiting
- Studio Dentistico Donati Di Donati Andrea & Mauro
-
Contact:
- Mauro Donati
-
-
Bolzano
-
Merano, Bolzano, Italy, 39012
- Recruiting
- Studio Odontoiatrico Maia Dentis
-
Contact:
- Antonio Bonaccorso, MD
-
Sub-Investigator:
- Teresa R Tripi, MD
-
-
Milano
-
Pioltello, Milano, Italy, 20096
- Recruiting
- Studio Medico Dentistico Dott. Mandelli
-
Contact:
- Federico Mandelli, MD
-
-
Pordenone
-
Chions, Pordenone, Italy, 33083
- Recruiting
- Studio Dentistico Bressan Associati Di Bressan Eriberto - Bressan Giuseppe - Bressan Paolo
-
Contact:
- Eriberto Bressan, MD, Prof.
-
-
Trento
-
Cembra, Trento, Italy, 38054
- Enrolling by invitation
- Studio Dentistico Associato Tomasi-Ghensi-Varotto
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test - Group A - Dentsply biomaterials
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".
|
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.
|
Active Comparator: Active comparator - Group B - Geistlich biomaterials
Dental extraction socket treated with the combined use of the xenogenic bone granules "Geistlich Bio-oss Collagen" and the resorbable collagen membrane "Geistlich BioGide".
|
Treatment of the dental extraction socket with the combined use of a well-known xenogenic bone granules and a resorbable collagen membrane
|
No Intervention: Control - Group C - Spontaneous healing
Spontaneous postextraction alveolar healing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composition of new-formed hard tissue into the post-extractive socket
Time Frame: Six months after surgery
|
Amount of mineralized bone, residual biomaterial, fibrous tissue
|
Six months after surgery
|
Composition of new-formed soft tissue over the post-extractive socket
Time Frame: Six months after surgery
|
Amount of epithelial tissue, connective tissue, of neovascularization, inflammatory cells, residual collagenic biomaterial
|
Six months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implant torque at insertion
Time Frame: Six months after surgery, at implant insertion.
|
Dynamometric measurement of the insertion torque at implant placement
|
Six months after surgery, at implant insertion.
|
Width of keratinized mucosa
Time Frame: Six months after surgery, at implant insertion.
|
Extension of keratinized mucosa in the bucco-lingual direction
|
Six months after surgery, at implant insertion.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Francesco Tessarolo, PhD, Bruno Kessler Fundation, Trento Italy
- Principal Investigator: Paolo Ghensi, DDS, PhD, Università degli Studi di Trento
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- I-BI-16-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Edentulous Alveolar Ridge
-
Mashhad University of Medical SciencesCompletedAtrophy of Edentulous Alveolar Ridge | Alveolar Ridge AugmentationIran, Islamic Republic of
-
Ain Shams UniversityNot yet recruitingEvaluation of Marginal Bone Loss of Two Immediately Loaded Implants Retaining Mandibular OverdentureEdentulous Alveolar RidgeEgypt
-
ARDEC AcademyUniversidad Nacional de TrujilloRecruiting
-
ahmed ashraf abdelreheemRecruiting
-
Paolo PesceCompletedEdentulous Alveolar RidgeItaly
-
University of BaghdadCompletedEdentulous Alveolar RidgeIraq
-
Fundación Eduardo AnituaBTI S.LActive, not recruitingEdentulous Alveolar RidgeSpain
-
Cairo UniversityUnknown
Clinical Trials on Treatment of the dental extraction socket using newly-released biomaterials
-
Aristotle University Of ThessalonikiUniversity Paul Sabatier of ToulouseRecruiting
-
Damascus UniversityCompletedDental Caries | Primary Teeth | PulpotomySyrian Arab Republic
-
Damascus UniversityActive, not recruitingAnesthesia, Local | Dental Anxiety | Behavior, ChildSyrian Arab Republic