Socket Preservation for Dental Implant Site Development.

Imam Abdulrahman Al Faisal Hospital

Status: Unknown

Conditions: Bone Loss

Treatments: Other: CopiOs® Cancellous Particulate; Other: Puros® Allograft

Study type: Interventional

Funder types: Other

Identifiers

NCT03112772

2014342

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 3 patient groups

Group I

Experimental group

Description:

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).

Treatment:

Other: Puros® Allograft

Group II

Experimental group

Description:

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).

Treatment:

Other: CopiOs® Cancellous Particulate

Group III

No Intervention group

Description:

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