Effect of Healing Time on New Bone Formation Following Tooth Extraction and Ridge Preservation With Demineralized Freeze-Dried Bone Allograft

NCT02154386 | Completed Results

• 1 other identifier: HSC20130440H
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Bone grafting following tooth extraction is commonly performed to preserve bony ridge dimensions adequate to support subsequent implant placement. Alveolar ridge resorption commonly occurs following tooth extraction, and the decrease in bone volume has the potential to make dental implant therapy impossible without surgery to reconstruct the ridge. The aim of ridge preservation grafting is to prevent or minimize this resorptive process, thereby preserving an adequate volume of bone for implant placement. Ridge preservation generally involves placement of a particulate bone graft material in the tooth socket, followed by use of a membrane or similar substance over the socket entrance to contain the bone graft. Various grafting materials have been recommended for these ridge preservation procedures, including demineralized freeze-dried bone allograft (DFDBA). The timing of dental implant placement following ridge preservation procedures is controversial, and few studies have examined the effects of different healing time intervals between ridge preservation and implant placement. The purpose of this project is to evaluate the formation of new bone at a site where tooth extraction has been performed followed by grafting using DFDBA. Two different study groups are included, one having the dental implant placed 8-10 weeks after tooth extraction and ridge grafting, the other having the dental implant placed 18-20 weeks after extraction and grafting.

Conditions

Bone Augmentation

Keywords

bone augmentation; tooth extraction; dental implant

Outcome Measures

Primary Outcomes (1)

• Percent New Vital Bone Formation

  Bone core biopsy will be evaluated histologically for percent new vital bone formation

  after removal of bone core from site of dental implant placement at 18-20 weeks following tooth extraction and grafting

Secondary Outcomes (2)

• Change in Ridge Width

  at time of implant placement at 8-10 or 18-20 weeks following tooth extraction and grafting

• Change in Buccal Ridge Height

  at time of implant placement at 8-10 or 18-20 weeks following tooth extraction and grafting

Study Arms (2)

8-10 week healing group

EXPERIMENTAL

dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting

Device: Ridge preservation using DFDBA

18-20 week healing group

ACTIVE COMPARATOR

dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting

Device: Ridge preservation using DFDBA

Interventions

Ridge preservation using DFDBA DEVICE

tooth extraction followed by ridge preservation grafting using DFDBA

18-20 week healing group; 8-10 week healing group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient currently a patient at dental school or eligible for treatment at dental school
• Patient resides within 50 mile radius of dental school
• A single rooted tooth that has been identified by dental faculty as requiring extraction
• Have adequate restorative space for a dental implant-retained restoration
• Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
• Have a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50% of the total depth of the socket.
• Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential.

You may not qualify if:

• Active localized or systemic infection other than periodontitis.
• Inadequate bone dimensions or restorative space dimensions to place a dental implant
• Presence of a disease entity, medical condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, autoimmune diseases, history of bisphosphonate use or long-term steroid therapy.
• Positive medical history of endocarditis following oral or dental surgery.
• Sensitivity or allergy to Bacitracin, Gentamicin, Polymyxin B Sulfate, alcohol and/or surfactants (per package insert)

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

UT Health Science Center School of Dentistry

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Whetman J, Mealey BL. Effect of Healing Time on New Bone Formation After Tooth Extraction and Ridge Preservation With Demineralized Freeze-Dried Bone Allograft: A Randomized Controlled Clinical Trial. J Periodontol. 2016 Sep;87(9):1022-9. doi: 10.1902/jop.2016.160139. Epub 2016 Apr 30.

  PMID: 27133791 DERIVED

Results Point of Contact

• Title: Dr. Brian Mealey
• Organization: UT Health Science Center San Antonio (School of Dentistry)

mealey@uthscsa.edu

210-567-3567

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Program Director, Periodontics

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: June 3, 2014
• Study Start: October 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 3, 2015
• Results First Posted: November 3, 2015

Record last verified: 2015-11

Locations

US (1)