Clinical trial NCT03897010: Evaluation of Silica-calcium Phosphate Composite in Socket Augmentation
Official title: Alveolar Ridge Augmentation Using Resorbable Bioactive Silica-calcium Phosphate Composite (SCPC): Clinical and Histology Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ridge Deficiency
Keywords: Silica-calcium phosphate composite
Socket augmentation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ideal bone graft should possess osteogenic, osteoinductive, and osteoconductive properties. Unfortunately, all of these are solely found within the autogenous graft that is available only in limited quantities, and it is associated with substantial post-surgical morbidity, However in this study Silica-calcium phosphate composite (SCPC) confirmed clinically, radiographically, histomorphometricand immunohistochemically the vitality and functionality of the newly formed bone. Histology and immunohistochemistry demonstrated maturation of the newly formed bone as indicated by presence of osteocytes, Haversian systems, blood vessels, compact mineralized collagen type I and high immune staining for osteopontin.

Detailed description: Alveolar ridge resorption following teeth extraction leads to 50% loss in bone width over one year period which corresponds to 5 -7 mm mainly from the buccal rather than palatal\\lingual aspects. Several calcium phosphates from bovine and synthetics sources are used for preservation of extraction socket; however with variable degrees of success. The aim of the present study is to evaluate clinically, radiographically and histologically the effect of Silica-calcium phosphate composite (SCPC) granules on new bone formation qualitatively and quantitatively following socket augmentation. This case series study was performed in five (n = 5) participants (one male and four females), all participants underwent socket augmentation procedures and dental implant placement in a staged approach. All participants were fully informed about the procedures, including the surgery, bone substitute materials and implants. Each participant had one extraction socket to be grafted with silica-calcium phosphate SCPC dental bone graft granules and the contralateral socket served as ungrafted control. Clinical, radiographic and histological evaluation was assessed.

Eligibility criteria: Inclusion Criteria:

* Patients require extraction of bilateral non-restorable (premolar or anterior) tooth located in the maxillary arch and need implant restoration.
* Teeth to be extracted are free from acute periapical infection or active periodontitis.
* Buccal plate of bone is intact
* Systemic free patients
* Patients were able to swallow tablets.

Exclusion Criteria:

* Patients with remaining root accompanied with acute periapical infection or sinus tract
* Insulin dependent diabetes patients.
* Thyroid disease patients.
* Smoker´s patients
* Patients with compromised health (ASA (III or IV) - according to the classification of American Society of Anaesthesiology including drug or alcohol abuse or any significant systemic disease.

Primary outcomes:
measure: Clinical outcome
timeFrame: 5 months
measure: Clinical outcome
timeFrame: 5 months
measure: Histological outcome
timeFrame: 7 months
Secondary outcomes:
measure: Immunohistochemical analysis
timeFrame: 7 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
citation: Adel-Khattab D, Afifi NS, Abu El Sadat SM, Aboul-Fotouh MN, Tarek K, Horowitz RA. Bone regeneration and graft material resorption in extraction sockets grafted with bioactive silica-calcium phosphate composite (SCPC) versus non-grafted sockets: clinical, radiographic, and histological findings. J Periodontal Implant Sci. 2020 Dec;50(6):418-434. doi: 10.5051/jpis.2000040002.