Evaluation of Silica-calcium Phosphate Composite in Socket Augmentation

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Ridge Deficiency

Treatments: Device: Socket Graft

Study type: Interventional

Funder types: Other

Identifiers

NCT03897010

121812

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups, including a placebo group

Silica-calcium phosphate composite Group

Active Comparator group

Description:

Participants underwent socket augmentation procedures and dental implant placement in a staged approach. Atraumatic extraction of badly decayed tooth was performed. The socket was debrided with curettes and alveolar spoons; the granulation tissue was carefully removed. Free gingival gingival graft (1.5 to 2 mm thick) was taken from the area between the first and second premolar, 5 mm from gingival margin. Bioactive porous SCPC dental bone graft granules in the size range 90-710 micron were mixed with saline and loosely packed in the extraction sockets as per the manufacturer. The grafted SCPC granules were covered with free gingival graft obtained from the palatal tissues and sutured to stabilize the grafting material in place.

Treatment:

Device: Socket Graft

Control Group

Placebo Comparator group

Description:

Participants underwent atraumatic extraction of badly decayed tooth was performed. The socket was debrided with curettes and alveolar spoons; the granulation tissue was carefully removed. The socket left to heal.

Treatment:

Device: Socket Graft