Treatment of Post-Extraction Dehisced Socket - A Case Series Study

NCT02980211 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 201612718
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

PURPOSE The purpose of this case series is to clinically, radiographically and histologically evaluate the treatment of dehiscence defects in extraction sockets using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane. METHODS Subjects with single-rooted teeth indicated for extraction and interested in future implant therapy for tooth replacement will be recruited on the basis of an eligibility criteria. A buccal or lingual dehiscence defect must strongly be suspected or confirmed upon clinical examination in order for the subject to qualify for study inclusion. A cone-beam computer tomography (CBCT) scan of the arch containing the tooth to be extracted will be obtained prior to tooth extraction. Following minimally invasive tooth extraction and debridement, the socket will be evaluated to verify the presence of a dehiscence defect affecting at least 50% of the bony plate height. After creating a soft tissue 'pouch' using tunneling instruments, a non-absorbable dense-PTFE (dPTFE) barrier membrane that will be trimmed to a size and shape that would allow for complete extension over the existing defect will be tucked between the mucosa and the alveolar bone. Then, the extraction socket will be grafted with particulate allograft and the access to the socket will be sealed with an extension of the membrane and an external cross mattress suture. Subjects will be recalled at 1, 2 and 5 weeks to monitor healing and assess the level of discomfort using a visual analog scale at the end of each visit. At the 5-week visit, the membrane will be gently removed and the exposed area will be left to heal by secondary intention. At 20 weeks after tooth extraction a second CBCT will be obtained to radiographically evaluate the site for implant placement. Bone volumetric reconstructions of the alveolar ridge at baseline and at 20 weeks will be made using the CBCT data to assess changes affecting the bone housing. If the site has healed adequately, implant placement will be planned at 24 weeks after tooth extraction. A bone core biopsy will be obtained at the time of implant placement in order to histologically analyze the characteristics of the grafted substrate. Upon implant placement with primary stability a healing abutment will be placed and sutures will be given to achieve primary wound closure, as necessary. Subjects will return for the final study visit at 2 weeks following implant placement to evaluate the healing prior to being referred back to the restorative dentist.

Conditions

Tooth Loss

Keywords

Alveolar Bone; Alveolar Ridge; Bone Resorption; Bone Grafting; Barrier Membrane

Outcome Measures

Primary Outcomes (1)

• Bone Volumetric Reduction From Baseline to 20 Weeks Post-extraction

  Alveolar bone volumetric reduction from baseline to 20 weeks using CBCT scans

  Baseline and 20 weeks post-extraction

Study Arms (1)

Tooth Extraction and Graft Dehisced Socket

EXPERIMENTAL

Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.

Drug: Alveolar Ridge Reconstruction

Interventions

Alveolar Ridge Reconstruction DRUG

Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane

Tooth Extraction and Graft Dehisced Socket

Eligibility Criteria

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

You may qualify if:

• Provision of informed consent
• Age: 18 years or older
• Subjects with a single-rooted tooth indicated for extraction bounded by stable, natural teeth
• Tooth planned for extraction must have a dehiscence defect in the surrounding bone, observed clinically and/or radiographically, that affects at least 50% of the bone height
• Subjects must be interested in replacing the tooth with a single implant-supported fixed restoration
• Subjects must be able and willing to follow instructions related to the study procedures
• Subjects must have read, understood and signed an informed consent form

You may not qualify if:

• Mandibular incisors
• Subjects with a history of organ failure (e.g. liver, kidney)
• Subjects with severe hematologic disorders, such as hemophilia or leukemia
• Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as osteoporosis, thyroid disorders or Paget's disease
• Subjects taking any medication or supplement known to largely influence bone metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or chronic intake of glucocorticoids
• Pregnant women (as indicated by positive serum HCG test) or nursing mothers
• Subjects with conditions that would result in compromised healing (e.g. poorly controlled diabetes, active heavy tobacco use \[\>10 cigs/day\])
• Subjects who, at the discretion of the investigators, would be unsuitable candidates for the study due to safety, psychological or practical reasons (e.g. known allergies to any product used for the study, limited mouth opening, etc.)

Sponsors & Collaborators

• Gustavo Avila-Ortiz DDS, MS, PhD: lead
• Osteogenics Biomedical: collaborator

Study Sites (1)

University of Iowa College of Dentistry - Craniofacial Clinical Research Program

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Tooth Loss; Bone Resorption

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Dr. Gustavo Avila-Ortiz, Professor and Chair, Department of Periodontics
• Organization: University of Iowa College of Dentistry

gustavo-avila@uiowa.edu

3193357241

Study Officials

• Gustavo Avila-Ortiz, DDS, MS, PhD

  College of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 2, 2016
• Study Start: March 1, 2017
• Primary Completion: May 3, 2018
• Study Completion: May 17, 2018
• Last Updated: February 5, 2020
• Results First Posted: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)