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

NCT02632734 | Unknown DMC

• 1 other identifier: CoreBone.CTIL
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bone Loss

Keywords

alveolar bone preservation; coral grafting device

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• preferred device for socket preservation

  2year

Study Arms (2)

CoreBone Cone device

EXPERIMENTAL

Experimental: CoreBone Cone device After extraction intervention will include the placement of CoreBone Cone device derived from coral that its dimensions is 4-5mm width and 8-10mm height. One cone for each extraction socket.Its advantage is that it fits well the socket site.Measurements from models taken at different times will be analysed for bone loss. Changes in width and height of alveolar bone will be studied at 3 and 6 month. We predict that CoreBone Cones are more effective than particulate device.

Device: CoreBone Cone device

CoreBone 500 device

EXPERIMENTAL

After extraction intervention will include the placement of CoreBone500 device derived from coral that is particulate. 0.3-0.5cc for each extraction socket.Its advantage is that it fills well the socket site.Measurements from models taken at different times will be analysed for bone loss. Changes in width and height of alveolar bone will be studied at 3 and 6 month.

Device: CoreBone 500 device

Interventions

CoreBone Cone device DEVICE

coral derived devices in the form of Cones are placed in extraction sites for preservation of bone during 6month and more.

CoreBone Cone device

CoreBone 500 device 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.

CoreBone 500 device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy individuals

You may not qualify if:

• smoking
• wound healing is disturbance

Sponsors & Collaborators

• The Baruch Padeh Medical Center, Poriya: lead

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in maxillofacial department

Study Record Dates

• First Submitted: November 8, 2015
• First Posted: December 17, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: December 17, 2015

Record last verified: 2015-12