Socket Preservation for Dental Implant Site Development.

NCT03112772 | Unknown

• 1 other identifier: 2014342
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Changes in alveolar bone following teeth extraction can compromise implant placement. Socket preservation (alveolar ridge preservation) is considered as a surgical procedure employed to preserve the ridge volume within the envelope existing at the time of extraction.The ultimate aim of such procedure is to compensate the expected amount of horizontal and vertical alveolar bone resorption. In order to better understand which socket preservation materials might be more effective for ridge preservation and to strengthen the evidence that is relevant to the clinicians' choice of socket preservation materials, two different materials were compared in a randomized controlled approach. (1) Demineralized Bone Matrix (DBM) Putty and Putty with Chips allograft covered by collagen membrane, and (2) Deprotonated bovine bone xenograft covered by collagen membrane. The independent variable is the grafting material while the dependent variables are the change in socket height, and width; the ability of implant placement without the need for grafting and the success rate of implants at the time of loading.

Conditions

Bone Loss

Outcome Measures

Primary Outcomes (3)

• Width of alveolar ridge

  The distance from the buccal to the lingual surface of the alveolar ridge

  4 months

• height of the alveolar ridge

  The distance from the crest of the ridge to the base of the socket

  4 months

• Need of further grafting at the time of implant placement

  Ability to place implants

  4 months

Secondary Outcomes (1)

• Osseintegration of implants

  4 months

Study Arms (3)

Group I

EXPERIMENTAL

Participants who are receiving socket preservation using allograft (Puros® Allograft, Zimmer dental, Zimmer, USA) covered by membrane (size: 15x20mm) made of type I collagen fibers purified from bovine tendon (BioMend® Membrane, Zimmer dental, Zimmer, USA).

Other: Puros® Allograft

Group II

EXPERIMENTAL

Participants who are receiving socket preservation cancellous particulate bovine bone xenograft (CopiOs® Cancellous Particulate, Zimmer dental, Zimmer, USA) covered by membrane (size: 15x20mm) made of type I collagen fibers purified from bovine tendon (BioMend® Membrane, 15x20mm, Zimmer dental, Zimmer, USA).

Other: CopiOs® Cancellous Particulate

Group III

NO INTERVENTION

No grafting materials will be inserted, so it serves as a negative control group.

Interventions

Puros® Allograft OTHER

It is a type of bone grafting materials used for enhancing bone formation

Group I

CopiOs® Cancellous Particulate OTHER

It is a type of bone grafting materials used for enhancing bone formation

Group II

Eligibility Criteria

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

You may qualify if:

• Adult patient \> 18 years old.
• Single and or multi-rooted teeth that are non-restorable.
• Patients are keen to have implant placement at the extraction sites after 4 months of extraction.
• Intact buccal bone after extraction, which was confirmed by visual inspection and clinical examination using a periodontal probe.
• Patients are medically fit with no underlying systemic diseases.

You may not qualify if:

• Pregnant females.
• Smokers.
• Presence of any acute infection at the time of teeth extraction.

Sponsors & Collaborators

• Imam Abdulrahman Al Faisal Hospital: lead

Study Sites (1)

Immam Abdulrahman Bin Faisal University

Dammam, Eastern Province, 31441, Saudi Arabia

Location

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor and Consultant of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: April 8, 2017
• First Posted: April 13, 2017
• Study Start: March 20, 2017
• Primary Completion: July 20, 2017
• Study Completion: November 20, 2017
• Last Updated: April 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

SA (1)