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A Comparison Between Primary and Secondary Flap Coverage in Extraction Sites: A Pilot Study

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ClinicalTrials.gov Identifier: NCT03136913
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Tufts University School of Dental Medicine

Tracking Information
First Submitted Date  ICMJE April 27, 2017
First Posted Date  ICMJE May 2, 2017
Last Update Posted Date May 8, 2017
Actual Study Start Date  ICMJE February 17, 2015
Actual Primary Completion Date April 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2017)
Mean difference in alveolar bone height change [ Time Frame: Up to 5 months post extraction and ridge preservation ]
Models/casts will be made in stone using the impressions. A stent will be made to measure the height and width of the alveolar ridge. Ridge height will be measured before tooth extraction, and 3-5 months after ridge preservation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
  • Post-operative pain/discomfort [ Time Frame: Up to 16 days post extraction and ridge preservation ]
    Subjects will be asked to rate their pain/discomfort on a visual analog scale (VAS) questionnaire (scale of 0-10)
  • Percentage new bone formation [ Time Frame: Up to 6 months post extraction and ridge preservation ]
    Histomorphometric analysis of bone core biopsy to determine percent new bone formation
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2017)
  • Post-operative pain/discomfort [ Time Frame: Up to 16 days post extraction and ridge preservation ]
    Subjects will be asked to rate their pain/discomfort on a VAS questionnaire (scale of 0-10)
  • Percentage new bone formation [ Time Frame: Up to 6 months post extraction and ridge preservation ]
    Histomorphometric analysis of bone core biopsy to determine percent new bone formation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison Between Primary and Secondary Flap Coverage in Extraction Sites: A Pilot Study
Official Title  ICMJE A Comparison Between Primary and Secondary Flap Coverage in Extraction Sites: A Pilot Study
Brief Summary This study is being conducted to compare the outcomes of two separate surgical techniques used in tooth extraction and ridge preservation. Ridge preservation is done to potentially minimize the amount of bone loss that occurs between the tooth extraction and implant or bridge placement, as compared to leaving the extraction site empty. There are two techniques that are commonly used for these procedures, either to close the surgical site of the extracted tooth with sutures (closed flap technique) or to leave the extraction site open to heal naturally (open flap technique). In the open flap technique there will be sutures used to secure and hold down the material used to cover the wound, called a non-resorbable membrane. The flaps will remain in their natural position, the site will fill up naturally with new tissue from the bottom up and then close itself in from the sides. The investigators want to see which technique offers better healing and reduces bone loss.
Detailed Description

Study design will be a single center, randomized controlled trial, split mouth designed study, to compare the bone dimensional changes following extraction and ridge preservation in surgical techniques that leave the flap open and closed.

The primary aim of this study is to evaluate the bone dimensional changes following extraction and ridge preservation with primary coverage (closed flap technique) in comparison to secondary intention (open flap technique).

The investigators hypothesize that the closed flap technique will have more potential to maintain vertical bone height when compared with the open flap technique, due to less susceptibility from infection and inflammation.

Secondary aim is to evaluate patients' self-report of postoperative discomfort. The investigators hypothesize that open flap technique will have less post-operative pain/discomfort due to less flap dissection and elevation when compared to closed flaps.

Tertiary aim is to have a histomorphometric examination and to assess the formation of new bone.

The investigators hypothesize that better bone volume percentage will be observed in closed flap technique when compared to open flap technique.

The primary outcome is the mean difference in alveolar bone height change between groups.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Loss of Teeth Due to Extraction
Intervention  ICMJE
  • Device: Cytoplast® TXT-200
    Non-resorbable membrane
  • Device: MinerOss® Cortical and Cancellous Chips (FDBA)
    Mixture of allograft mineralized cortical and cancellous chips
  • Procedure: Open Flap Technique
    After extraction, the socket wound is left open to heal by secondary intention
  • Procedure: Closed Flap Technique
    After extraction, the socket wound is closed by primary closure
Study Arms  ICMJE
  • Active Comparator: Closed Flap Technique
    Healing by primary intention: Extraction and ridge preservation, utilizing non-resorbable membrane (Cytoplast® TXT-200 ) and freeze dried bone allograft (MinerOss® Cortical and Cancellous Chips (FDBA)), with flaps in primary coverage.
    Interventions:
    • Device: Cytoplast® TXT-200
    • Device: MinerOss® Cortical and Cancellous Chips (FDBA)
    • Procedure: Closed Flap Technique
  • Active Comparator: Open Flap Technique
    Healing by secondary intention: Extraction and ridge preservation, utilizing non-resorbable membrane (Cytoplast® TXT-200) and freeze dried bone allograft (MinerOss® Cortical and Cancellous Chips (FDBA)), with flaps in position for healing by secondary intention.
    Interventions:
    • Device: Cytoplast® TXT-200
    • Device: MinerOss® Cortical and Cancellous Chips (FDBA)
    • Procedure: Open Flap Technique
Publications * Aladmawy MA, Natto ZS, Steffensen B, Levi P, Cheung W, Finkelman M, Ogata Y, Hur Y. A Comparison between Primary and Secondary Flap Coverage in Ridge Preservation Procedures: A Pilot Randomized Controlled Clinical Trial. Biomed Res Int. 2019 Aug 20;2019:7679319. doi: 10.1155/2019/7679319. eCollection 2019.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2017)
13
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 11, 2016
Actual Primary Completion Date April 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient who is treatment planned at Tufts University School of Dental Medicine (TUSDM) for extraction and future implant placement and meet all medical and dental requirements of the TUSDM periodontology clinic for periodontal surgery (e.g., subjects with no diseases or medication allergies contraindicating periodontal surgery).

    • Patient must have bilateral extraction (canine to molar) sites of teeth located on the same arch (e.g. upper right and upper left) treatment planned for future implant placement at TUSDM.
    • The number of teeth planned for extraction (either one or two adjacent) and ridge preservation should match the same number of teeth (either one or two adjacent) from the contra-lateral side on the same arch.
    • Presence of at least 3 intact bony walls and at least half of the fourth bony wall at each site as determined by bone sounding at Visit 1.

Exclusion Criteria:

  • Have any known disease that interferes with periodontal surgery and would not allow the patient to be treatment planned for the procedures in the TUSDM periodontology clinic (e.g., severe anemia, low white blood cell count, bleeding or coagulation disorder, uncontrolled hypertension (150/90), recent myocardial infarction (within 6 months of enrollment), diabetes (HbA1C ≥7%), HIV/AIDS (self-reported), history of or currently undergoing head and neck radiation, history of or currently taking bisphosphonates).

    • Subject who has a disease or condition that may affect hard and soft tissue healing (e.g., previous or current head and neck radiation therapy, long term steroid use defined as more than two weeks in the past two years).
    • Subject who has diseases that affect bone metabolism (e.g., osteoporosis, osteopenia).
    • Pregnancy (self-reported)
    • Current Smokers
    • Extraction socket with > 50% bone loss on the buccal or lingual/palatal bone as determined by bone sounding at Visit 1.
    • Allergic to gentamycin, povidone-iodine, or surfactants as trace amounts may be contained in the MinerOss®
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03136913
Other Study ID Numbers  ICMJE 11441
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tufts University School of Dental Medicine
Study Sponsor  ICMJE Tufts University School of Dental Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yong Hur, DMD, MSc TUSDM
PRS Account Tufts University School of Dental Medicine
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP