Socket Preservation for Dental Implant Site Development.

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.

Study Overview

• Status: Unknown
• Conditions: Bone Loss
• Intervention / Treatment: Other: Puros® Allograft; Other: CopiOs® Cancellous Particulate

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Eastern
    • Dammam, Eastern, Saudi Arabia, 31441
      • Immam Abdulrahman Bin Faisal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group I; 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; It is a type of bone grafting materials used for enhancing bone formation
EXPERIMENTAL: Group II; 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; It is a type of bone grafting materials used for enhancing bone formation
NO_INTERVENTION: Group III; No grafting materials will be inserted, so it serves as a negative control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osseintegration of implants	Implant loss before restoration	4 months

Collaborators and Investigators

• Sponsor: Imam Abdulrahman Al Faisal Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2017
• Primary Completion (ANTICIPATED): July 20, 2017
• Study Completion (ANTICIPATED): November 20, 2017

Study Registration Dates

• First Submitted: April 8, 2017
• First Submitted That Met QC Criteria: April 8, 2017
• First Posted (ACTUAL): April 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 15, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2014342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available after statistical analysis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No