The Use of CoreBone Coral Particles vs. Cones for Preservation of Alveolar Bone

Bone Loss Clinical Trial

— CoreBone  

Official title:

Comparison Between CoreBone Coral Particles and CoreBone Coral Cones as Graft After Extraction Sockets for Alveolar Ridge Preservation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02632734
• Other study ID #: CoreBone.CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: November 8, 2015
• Last updated: December 14, 2015
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: December 2015
• Source: The Baruch Padeh Medical Center, Poriya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Normally, dentists do not graft the socket after extraction of teeth. When they do graft they use particulate graft devices. The purpose of this study is to examine whether coral particles of 300-450um in comparison to coral cones of 4-5mm wide and 8-10 mm long will preserve alveolar ridge of maxilla or mandible when grafted immediately after tooth extraction. The coral grafting devices are processed from Porites corals grown in aquariums, under controlled environment. The devices are cleansed and sterilized by gamma irradiation. The measurements during follow ups will be performed from CT x rays and measurements by caliber and models.The width and height measurements from follow up x rays and models. The study will be performed on 10 patients, that two parallel teeth are diagnosed to be extracted, in same patient.The data will be analysed for bone loss and compared to previous published studies. Also comparison between two devices will be performed.

Description:

Normally, dentists do not graft the socket after extraction of teeth. When they do graft they use particulate graft devices.The purpose of this study is to examine whether coral particles of 300-450um in comparison to coral cones of 4-5mm wide and 8-10 mm long will preserve alveolar ridge of maxilla or mandible when grafted immediately after tooth extraction.

Methods: 10 patients adults that are diagnosed for extraction of same tooth number ,each on different side of jaw. A non traumatic extraction will be performed, on both sides, sometimes not on same date. After extraction, coral device 'CoreBone500' sterile particles will fill the extraction site. Usually 0.3cc will be used. On the other side of same jaw 'CoreBone' Cone sterile of 4-5mm width and 8-10mm height will be placed in socket. Sutures will be placed and efforts will be put in covering the opening by soft tissues. Follow up of the alveolar ridge preservation will be performed using CT at time of grafting and 6 month later. Measurements during follow ups will be performed by caliber the width and height of alveolar ridge 2 weeks, 3month and 6 month follow up. A clinical follow up of healing soft tissues after grafting and patients complaints of pain will be addressed. If any unusual complaints from patients appears the study will be terminated immediately. From our preclinical studies no adverse effects were found. The analysis of data will be statistically analysed and compared to published data. We expect that CoreBone Cones are more effective in ridge preservation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• healthy individuals

Exclusion Criteria:

• smoking

• wound healing is disturbance

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Loss

Intervention

Device:
• CoreBone Cone device
coral derived devices in the form of Cones are placed in extraction sites for preservation of bone during 6month and more.
• CoreBone 500 device
coral derived devices in the form of particulate (CoreBone 500) are placed in extraction sites for preservation of bone. Follow up during 6month and more.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Baruch Padeh Medical Center, Poriya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone loss will be measured from dental impression models of the grafted site by caliper	The bone loss will be measured from dental impression models of the grafted site that will be taken 2 weeks,3 month,6 month after grafting,using a caliper for measurements from models.	2 weeks, 3 month, 6 month after grafting	No
Secondary	preferred device for socket preservation	In addition a comparison between bone loss when CoreBone500 device will be grafted and CoreBone Cone.	2year	No