Skip to main content
OpenTrials
Completed

NCT Number: NCT03897010

Evaluation of Silica-calcium Phosphate Composite in Socket Augmentation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ridge Deficiency

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University

Cairo, 11765, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: socket augmentation, Socket preservation

Primary outcomes

  1. Clinical outcome

    Time frame: 5 months

    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.

  2. Clinical outcome

    Time frame: 5 months

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

  3. Histological outcome

    Time frame: 7 months

    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.

Secondary outcomes

  1. Immunohistochemical analysis

    Time frame: 7 months

    Evaluation of Osteopontin expression in the newly formed bone.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Alveolar Ridge Augmentation Using Resorbable Bioactive Silica-calcium Phosphate Composite (SCPC): Clinical and Histology Evaluation

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 1, 2019
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.