Treatment of Post-Extraction Dehisced Socket - A Case Series Study
Condition: Tooth Loss
MeSH terms: Tooth Loss
Intervention: Alveolar Ridge Reconstruction
Intervention description: 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Alveolar Bone; Alveolar Ridge; Bone Resorption; Bone Grafting; Barrier Membrane

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.
    

Eligibility 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.)