Clinical trial NCT04789759: Biomaterial Clinical Performance in a Socket Preservation Model
Official title: Comparative Clinical Performance of Biphasic Calcium Sulfate Cement Matrix With Hydroxyapatite Granules in a Socket Preservation Model: a Pilot Clinical Trial Parallel Group Assignment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Loss
Alveolar Bone Resorption
Lead sponsor: International Advanced Dentistry, Lisbon
Sponsor class: NETWORK
First posted: 2021-03-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case Series of 10 consecutive cases , with one extraction (at least ) with a type 2 socket, Control group, 10 consecutive dental extractions.
Primary purpose: TREATMENT

Brief summary: When a dental extraction is performed, sequential cascade of events happens that lead to a modeling and remodeling of the area.

This phenomenon leads to bone resorption and consequential volume loss atrophy. In literature several biomaterials (Autogenous, alloplastic, allografts and xenografts) were tested as alveolar fillers with the aim of controlling this physiologic event.

Socket preservation is today a very widely spread dental technic to preserve the alveolar dimensions, that uses a wide range of biomaterials.

Alloplastic materials have a fair evidence to work in several regenerative procedures in the oral and maxillofacial region.

This pilot trial aims to characterize Histologic bone healing pattern in a human socket preservation model of 2/3 biphasic calcium sulfate cement matrix's and Hydroxyapatite (HA granules).

Alterations in Volumetric alveolar socket changes in a socket preservation clinical model will also be studied.

Detailed description: Aim : To evaluate histologic performance and volumetric outcome of a bone substitute used in dentistry for guided bone regeneration procedures.

Model : Human Socket preservation surgery with a control group of spontaneous alveolar healing.

Inclusion criteria includes a class 2 or 3 (loss of at least 1/3 of the buccal bone of the alveolar socket) post-extraction sockets.

Clinical Experimental Methodology :

Atraumatic extraction of the hopeless tooth without flap retraction, after socket mechanical debridement , fill with 2/3 biphasic calcium sulfate cement matrix's with Hydroxyapatite (HA granules) and covered with a resorbable membrane.

3 Month after a CBCT is performed for implant planning.

At implant placement a 2 mm trephine will be used for core extraction.

Measurements (Stl File) on the day of surgery (Baseline T0) and at implant placement (3 month after tooth extraction) (T1) and after delivery final crown (T2).

Discrepancy (Trueness) Between STL Files in Teeth Adjacent to Implant will be used at T0, T1 and T2.

Histologic measure comprise percentage of vital bone formation, fibrous/connective tissue, and material remnant, in a socket preservation model

To Measure Volumetric changes reverse engineering software (Geomagic Control X, 3D Systems) will be used.

Other evaluation parameters involve radiographic Cone Beam Computer Tomography evaluation, primary stability, implant survival and implant success rate

Clinical Control Methodology :

Atraumatic extraction of the hopeless tooth without flap retraction, after socket mechanical debridement Measurements (Stl File) on the day of surgery (Baseline T0) and at 3 month after tooth extraction) (T1) Discrepancy (Trueness) Between Standard Tessellation Language Files in Teeth Adjacent to Implant will be used at T0 and T1

Eligibility criteria: Inclusion Criteria:

1. Aged 18 or over
2. requiring extraction of teeth in the premolar region and anterior maxilla (15-25), presence of intact 2/3 or less, buccal bone plate
3. ASA (Physical Status Classification System, American Society of Anesthesiologist) I or II.

Exclusion Criteria:

1. patients with uncompensated systemic diseases, metabolic and healing disorders, i.e. diabetes mellitus, hyperparathyroidism, cancer, HIV,
2. heavy smokers (\>5 cigarettes/ day),
3. bone metabolic diseases,
4. severe renal dysfunction or liver disease,
5. had received systemic corticosteroids or other immunosuppressive agents, radiation therapy and/or chemotherapy for the past 2 months,
6. active infections in the surgical site
7. patients with periodontal or/and endodontic disease

Primary outcomes:
measure: Histologic Examination Histomorphometric Analysis
timeFrame: 3 month after tooth extraction
Secondary outcomes:
measure: Volumetric Changes Clinical
timeFrame: at pre-extraction and at final crown insertion up to 1 year
measure: Radiographic CBCT - Bone evaluation
timeFrame: at pre-extraction and at final crown insertion up to 1 year
measure: Primary and Secondary stability
timeFrame: at implant placement and at dental crown insertion up to 1 year
measure: Incidence of Implant Success rate
timeFrame: at final treatment (crown insertion) up to 1 year
measure: Implant probing depth
timeFrame: At implant insertion and At final treatment (crown insertion) up to 1 year
measure: Implant marginal bone loss.
timeFrame: at implant placement and at final crown insertion (up to 1 year)
measure: Incidence of Survival rate
timeFrame: at dental crown placement (final treatment) up to 1 year
Other outcomes:
Locations:
Study officials:
affiliation: International Advanced Dentistry
name: Andre Chen, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: International Advanced Dentistry
name: João Borges, Msc
role: STUDY_DIRECTOR
affiliation: International Advanced Dentistry
name: Elena Cervino, Msc
role: STUDY_CHAIR
affiliation: Augma Bio
name: Amos Yahav, DMD
role: STUDY_CHAIR
affiliation: Augma Bio
name: Ofir Yahav, DMD
role: STUDY_CHAIR
References: