Socket Preservation for Dental Implant Site Development.

Not Applicable

• Conditions: Bone Loss
• Interventions: Other: CopiOs® Cancellous Particulate; Other: Puros® Allograft

• Registration Number: NCT03112772
• Lead Sponsor: Imam Abdulrahman Al Faisal Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-20
• Status Verified: 2017-04
• Study First Submitted: 2017-04-08
• Study First Submitted QC: 2017-04-08
• Study First Posted: 2017-04-13
• Last Update Submitted: 2017-04-15
• Last Update Posted: 2017-04-18
• Primary Completion: 2017-07-20
• Study Completion: 2017-11-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

1. Pregnant females.
2. Smokers.
3. Presence of any acute infection at the time of teeth extraction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	CopiOs® Cancellous Particulate	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).
Group I	Puros® Allograft	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).

Primary Outcome Measures

Name	Time	Method
Width of alveolar ridge	4 months	The distance from the buccal to the lingual surface of the alveolar ridge
height of the alveolar ridge	4 months	The distance from the crest of the ridge to the base of the socket
Need of further grafting at the time of implant placement	4 months	Ability to place implants

Secondary Outcome Measures

Name	Time	Method
Osseintegration of implants	4 months	Implant loss before restoration

Trial Locations

Locations (1)

Immam Abdulrahman Bin Faisal University; 🇸🇦 Dammam, Eastern, Saudi Arabia