Evaluation of Silica-calcium Phosphate Composite in Socket Augmentation

NCT03897010 | Completed Phase 4 FDA Device

• 1 other identifier: 121812
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Ridge Deficiency

Keywords

Silica-calcium phosphate composite; Socket augmentation

Outcome Measures

Primary Outcomes (3)

• Clinical outcome

  Clinical parameters on the tooth to be extracted in both test and control groups were assessed. Buccal gingival thickness was measured using clinical reference points 4 mm away from the gingival margin by a graduated periodontal probe.

  5 months

• Clinical outcome

  Buccolingual bone width was measured by bone caliper 4 mm away from the gingival margins

  5 months

• Histological outcome

  histomorphometric measurement of amount of residual graft percent and amount of new vital bone formation in the newly formed bone. The sections were obtained from the core biopsy in 5µm thickness and were stained by Hematoxylin and Eosin.

  7 months

Secondary Outcomes (1)

• Immunohistochemical analysis

  7 months

Study Arms (2)

Silica-calcium phosphate composite Group

ACTIVE COMPARATOR

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.

Device: Socket Graft

Control Group

PLACEBO COMPARATOR

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.

Device: Socket Graft

Interventions

Socket Graft DEVICE

5 patients had bilateral decayed upper premolar or anterior teeth, in one side SCPC graft was inserted in socket and in the contralateral site was a control, 5 months months postoperative core biopsies were taken from both grafted sockets and control ungrafted sockets during implant insertion. The biopsy samples from SCPC-grafted and control ungrafted sockets were fixed, decalcified and embedded into paraffin wax. All samples were serially sectioned in serial 5μm-thin sections were stained separately with Hematoxylin and Eosin staining, Sirius red and Mason trichrome and immunostaining with osteopontin.

Also known as: socket augmentation, Socket preservation

Control Group; Silica-calcium phosphate composite Group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11765, Egypt

Location

Related Publications (1)

• 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.

  PMID: 33350181 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Periodontology, Faculty of Dentistry

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 1, 2019
• Study Start: November 20, 2017
• Primary Completion: February 1, 2019
• Study Completion: February 15, 2019
• Last Updated: April 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)