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Socket Preservation Procedure Studying Soft and Hard Tissue Outcomes

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ClinicalTrials.gov Identifier: NCT03497403
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
Valeant Pharmaceuticals
Information provided by (Responsible Party):
Heather Hong, Harvard School of Dental Medicine

Study Description
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Brief Summary:
Two different surgical protocols for socket preservation were compared. Soft and hard tissue outcomes were measured clinically and radiographically at baseline and six months post operatively.

Condition or disease Intervention/treatment Phase
Ridge Preservation Bone Regeneration Procedure: Socket preservation control Procedure: Socket preservation experimental Not Applicable

Detailed Description:
The effect of different surgical techniques for socket preservation on soft tissue parameters has seldom been investigated. The aim of this study was to evaluate One with a cross-linked membrane used in secondary intention healing and the other with a non-cross-linked membrane used in primary intentional healing. Thirty subjects requiring tooth extraction were randomly allocated to either control group C (allograft covered with a non-cross-linked collagen membrane with primary closure) or experimental group E (allograft covered with cross-linked collagen membrane left exposed). Sites were surgically re-entered at 6-months. Soft and hard tissue measurements, cone beam computed tomography (CBCT) and cast measurements were taken at baseline & 6-months.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants were assigned to one of two groups in parallel for the duration of the study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Socket Preservation Revisited: RCT to Study the Three-dimensional Changes of Hard and Soft Tissue Comparing Two Distinct Surgical Protocols
Actual Study Start Date : October 18, 2016
Actual Primary Completion Date : April 19, 2017
Actual Study Completion Date : September 29, 2017
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control
Socket preservation control. After tooth extraction, bone graft is applied to socket and a non-cross-linked membrane is used in primary intentional healing.
 Procedure: Socket preservation control
After a tooth was extracted, the adjacent gum tissue was fully reflected, bone graft (FDBA) and non-cross-linked barrier membrane (Bio-Gide) were applied to the defect. The site was stabilized with sutures. Patients were followed for 6 months post operatively.
Experimental: Experimental
Socket preservation experimental. After tooth extraction, bone graft is applied to socket and a cross-linked membrane is used in secondary intention healing.
 Procedure: Socket preservation experimental
After a tooth was extracted, the adjacent gum tissue was minimally reflected, bone graft (FDBA) and cross-linked barrier membrane (OssixPlus) were applied to the defect. The site was stabilized with sutures. Patients were followed for 6 months post operatively.


Outcome Measures
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Primary Outcome Measures :
  1. Keratinized tissue width [ Time Frame: 6 months ]
    Keratinized gingival tissue width measured from the free gingival margin to the muco-gingival junction.


Secondary Outcome Measures :
  1. Keratinized tissue thickness [ Time Frame: 6 months ]
    Keratinized gingival tissue thickness measured with a needle and stopper 3mm from the free gingival margin.

  2. Vestibular Depth [ Time Frame: 6 months ]
    The distance from the free gingival margin to the apical extent of the vestibule measured with a probe.

  3. CEJ-FGM [ Time Frame: 6 months ]
    The distance from the tooth's cervical enamel junction (CEJ) to the free gingival margin (FGM) was taken with a probe.

  4. Ridge Width [ Time Frame: 6 months ]
    After the gum tissue is reflected, the width of the ridge 6mm from the crest was measured with a caliper.

  5. CEJ- Buccal crest [ Time Frame: 6 months ]
    The distance from the tooth's cervical enamel junction and the top of the buccal bone crest was taken with a probe.

  6. CBCT bone height [ Time Frame: 6 months ]
    CBCT scans were taken and the alveolar ridge height was then measured.

  7. CBCT bone width [ Time Frame: 6 months ]
    CBCT scans were taken and the alveolar ridge width was then measured.

  8. Cast ridge width [ Time Frame: 6 months ]
    Dental impressions were taken and stone casts obtained from them.The ridge width was then measured with calipers.

  9. Cast ridge volume [ Time Frame: 6 months ]
    Dental impressions were taken and stone casts obtained from them.The ridge volume was measured using an optical scanner.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. between 20-80 years of age
  2. healthy with no conditions that could alter wound healing
  3. requiring the extraction of a non-molar tooth with two neighboring teeth on either side and intact bony walls
  4. a tooth requiring extraction that is treatment planned for implant placement
  5. willing to participate in the study and sign the informed consent
  6. willing to receive clinical exams, radiographs, surgery, two and six week post-operative exams and six month re-entry exam.

Exclusion Criteria:

  1. systemic conditions which could alter wound healing
  2. tooth anatomy requiring aggressive bone removal or greater flap reflection for extraction
  3. severe local infection at extraction site
  4. a tooth exhibiting severe resorption of buccal or lingual plates
  5. absence of keratinized tissue buccal to the tooth to be extracted
  6. severely reduced vestibular depth (≤ 3.0 mm) at the tooth to be extracted.
Contacts and Locations
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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): NCT03497403


Locations
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United States, Massachusetts
Harvard School of Dental Medicine
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Harvard School of Dental Medicine
Valeant Pharmaceuticals
Investigators
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Principal Investigator: Eli Machtei, DMD Harvard School of Dental Med.
  Study Documents (Full-Text)

Documents provided by Heather Hong, Harvard School of Dental Medicine:
Informed Consent Form  [PDF] July 22, 2016
Study Protocol and Statistical Analysis Plan  [PDF] May 6, 2016

More Information
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Responsible Party: Heather Hong, Principle Investigator, Harvard School of Dental Medicine
ClinicalTrials.gov Identifier: NCT03497403    
Other Study ID Numbers: IRB15-3772
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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