Hyaluronic Acid and Polynucleotides in Ridge Preservation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25+
SponsorUniversity of Parma
About this trial
The aim of this study is to test the use of a bovine-derived bone graft combined with a polynucleotides-rich hyaluronic acid (PNHA) gel for the preservation of the bone after a tooth extraction (alveolar ridge preservation) and to test the performance of a fully-digital workflow to rehabilitate the site with a dental implant. 40 patients in need for a single tooth extraction will be recruited at Centro di Odontoiatria, Università di Parma and they will be randomly assigned to 2 groups: extraction and spontaneous healing or extraction and regeneration of the site with a bovine-derived bone graft combined with a PNHA gel. At 4 months after extraction an implant will be placed in the extraction site, which will be rehabilitated with a fully-digital workflow and patients will be followed up at up to 12 months post rehabilitation. Two 3D x-rays with a small field of view will be performed immediately after extraction and at 4 months post extraction to plan implant placement. These images will also be used to assess changes in the dimension of the post extraction bone (primary outcome). As part of the study different questionnaires will be administered to assess quality of life and perception of the therapy and the wound exudate in the area of the extraction will be collected non invasively with a collagen sponge to assess the expression of different proteins during the early healing days. On the day of implant placement a sample of bone tissue will also be collected as part of the bone drilling and histologically analysed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥25-year-old males and females;
good systemic health (self-assessment);
presence of an unrestorable/hopeless tooth with periodontal attachment and buccal bone preserved at least for 2/3rd of the root and not associated with acute periapical pathology;
full mouth bleeding and plaque scores ≤ 25%
Disqualifiers
uncontrolled or untreated periodontal disease;
history of local (head and neck) radiation therapy in the past 5 years;
acute endodontic lesion in the test tooth or in the neighbouring areas to the extraction procedure (sites with presence of an asymptomatic chronic lesion are eligible);
medical history that includes uncontrolled diabetes or hepatic or renal disease, or other serious medical conditions that can impact on bone metabolism (e.g. rheumatoid arthritis, osteoporosis) or transmittable diseases (e.g. HIV-related disease);
Trial design
Design model
Parallel
Treatments tested in this trial
regeneration of post extraction socket with biomaterials
Deviceafter tooth extraction, in the test group we will place a demineralised bovine bone graft mixed with a gel containing hyaluronic acid and polynucleotide and we will cover the entrance of the socket with a collagen matrix
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Spontaneous post extraction healingNo intervention 0 interventions
Group B: Alveolar ridge preservationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in alveolar ridge width at 4 months post extraction between study groups
This is a superiority outcome evaluating horizontal ridge width changes at four months post-extraction between test and contro group with the help of a CBCT scan.
Time frame
4 months after tooth extraction (visit 6)Secondary outcomes
1
quality of newly formed bone
to qualitatively assess socket healing and the maturity of the newly formed bone when DBBM combined with a PNHA and covered by a collagen matrix is employed for alveolar ridge preservation as compared to unassisted healing . A bone core biopsy will be taken at 4 months in both groups and the percentage of connective tissue, woven bone and mineralised bone calculated
Time frame
4 months post extraction (visit 6)2
3D volume changes
to assess 3D volume changes in soft and hard tissues at 4 and 12 months post extraction (this will be performed after digitally superimposing DICOM and STL files and in a selected region of interest) in the test and control groups
Time frame
4 months post extraction (visit 6)3
changes in protein expression
to assess and compare the expression of proteins and signalling pathways in the wound exudate at early healing stages. This will be done through full proteomic analysis via mass spectrometry of the wound exudate
Time frame
3, 7 and 14 days post extraction (Visit 3, 4, 5)4
Profilometric changes
to assess profilometric changes in the alveolar ridge via superimposition of intra oral scans of test and control groups
Time frame
3, 7, 14 days and at 4 months post extraction (visit 3, 4, 5)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Parma
Lead sponsor
Geistlich Pharma AG
Collaborator
Source ClinicalTrials.gov