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Treatment of Post-Extraction Dehisced Socket - A Case Series Study (OSTEO2)

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ClinicalTrials.gov Identifier: NCT02980211
Recruitment Status : Active, not recruiting
First Posted : December 2, 2016
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
Osteogenics Biomedical
Information provided by (Responsible Party):
Gustavo Avila-Ortiz, University of Iowa

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.


Condition or disease Intervention/treatment Phase
Tooth Loss Device: Ridge Reconstruction Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical, Radiographic and Histologic Evaluation of a Novel Alveolar Ridge Reconstruction Approach in Post-Extraction Dehiscence Defects: A Case Series Study
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tooth Extraction and Graft Dehisced Socket
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.
Device: Ridge Reconstruction
Tooth extraction will be attempted in minimally traumatic, flapless, fashion. Following tooth extraction, the existence of the suspected dehiscence defect will be confirmed; absence of a defect will result in subject exclusion from the study and the case will be considered an intent-to-treat. Horizontal and vertical dimensions of the defect will be measured using a UNC-15 probe. After creating a soft tissue 'pouch' using tunneling instruments, a non-absorbable dense-PTFE (dPTFE) [Cytoplast TXT-200, Osteogenics Biomedical] barrier membrane, trimmed to the size and shape that would allow for complete extension over the existing defect, will be tucked between the mucosa and the alveolar bone. The socket will then be grafted using a particulate bone allograft [EnCore, Osteogenics Biomedical] and the socket access will be sealed with an extension of the dPTFE membrane to ensure complete coverage of the bone graft and the crestal bone.




Primary Outcome Measures :
  1. Volumetric changes [ Time Frame: 20 weeks post-extraction ]
    Alveolar bone volumetric changes using CBCT scans



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA

  • 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

EXCLUSION CRITERIA

  • 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980211


Locations
United States, Iowa
University of Iowa College of Dentistry - Craniofacial Clinical Research Program
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Gustavo Avila-Ortiz
Osteogenics Biomedical

Responsible Party: Gustavo Avila-Ortiz, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT02980211     History of Changes
Other Study ID Numbers: 201612718
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Gustavo Avila-Ortiz, University of Iowa:
Alveolar Bone
Alveolar Ridge
Bone Resorption
Bone Grafting
Barrier Membrane

Additional relevant MeSH terms:
Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases