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Verify if Amelogenins Had Some Benefits in Improving Lower 2nd Molar Periodontal Healing After 3rd Molar Extraction

Primary Purpose

Attachment Loss, Periodontal, Teeth, Impacted

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Amelogenin
Placebos
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attachment Loss, Periodontal focused on measuring third molar surgery, amelogenin, periodontal pocket

Eligibility Criteria

18 Years - 27 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients aged < 27, for which the extraction of both lower third molars was indicated
  • Bilateral total (bone or osteo-mucosal) third molar impaction
  • Bilateral bone defect ≥ 5mm distal to the lower second molars, evaluated on pre- operative periapical radiographs performed with Rinn's film holders
  • PPD ≥ 8mm distal to the second lower molars, in at least one of the following probing sites: buccal, disto-buccal, disto-central, disto-lingual
  • Intra-operative integrity of both third molar buccal and lingual alveolar cortices

Exclusion Criteria:

  • Smoking habit
  • Systemic disorders with serious immunologic impairment
  • Taking cortisone or other drugs that might interfere with healing process
  • Allergy to penicillins
  • Previous periodontal treatment
  • Less than 2 mm of adherent gingiva at second molar level
  • Second molars with a prosthetic crown
  • Previous endodontic treatment of second molars
  • Furcation involvement of the second molars

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    amelogenins group

    placebo group

    Arm Description

    The study involved enrolling 5 periodontitis free patients, to which the extraction of both lower third molars was prescribed. A bone defect at the distal surface of the second molar ≥ 5 mm, had to be present on the intraoral periapical radiography, bilaterally. Amelogenins effect was evaluated by applying them only in the test site and comparing healing results with those obtained on the contra-lateral site

    The study involved enrolling 5 periodontitis free patients, to which the extraction of both lower third molars was prescribed. A bone defect at the distal surface of the second molar ≥ 5 mm, had to be present on the intraoral periapical radiography, bilaterally. In this group (control site) the conventional treatment was performed, and healing was ensured only by the simple blood clot

    Outcomes

    Primary Outcome Measures

    CAL (Clinical attachment level) pre operative
    CAL (Clinical attachment level) post operative
    CAL (Clinical attachment level) 3 months
    CAL (Clinical attachment level) 12 months
    PPD (Periodontal probing dept) pre operative
    PPD (Periodontal probing dept) post operative
    PPD (Periodontal probing dept) 3 months
    PPD (Periodontal probing dept) 12 months
    REC (recession) pre operative
    REC (recession) post operative
    REC (recession) 3 months
    REC (recession) 12 months
    Radiographic bone Level pre operative
    Radiographic bone Level post operative
    Radiographic bone Level 3 months
    Radiographic bone Level 12 months

    Secondary Outcome Measures

    Adverse Events pre operative
    the occurrence of adverse events after the use of amelogenins.
    Adverse Events post operative
    the occurrence of adverse events after the use of amelogenins.
    Adverse Events 3 months
    the occurrence of adverse events after the use of amelogenins.
    Adverse Events 12 months
    the occurrence of adverse events after the use of amelogenins.

    Full Information

    First Posted
    March 10, 2020
    Last Updated
    March 17, 2020
    Sponsor
    University of Roma La Sapienza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04314726
    Brief Title
    Verify if Amelogenins Had Some Benefits in Improving Lower 2nd Molar Periodontal Healing After 3rd Molar Extraction
    Official Title
    Usefulness of Amelogenins in the Treatment of Periodontal Defects on the Distal Surface of the Lower Second Molar After Adjacent Third Molar Extraction: a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    March 24, 2016 (Actual)
    Primary Completion Date
    April 20, 2018 (Actual)
    Study Completion Date
    April 20, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Roma La Sapienza

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Background: Prevention of periodontal defects after the extraction of lower third molars remains a challenge. Various methods have been proposed in the literature, but there are no studies which evaluated the effectiveness of amelogenins. Methods: A single-blind split-mouth randomized controlled clinical trial (RCT) was performed on 5 patients to verify if amelogenins had some benefits in improving lower second molar periodontal healing after adjacent third molar extraction. A PPD ≥ 8 mm associated with a radiographic bone defect of at least 5 mm were the main inclusion criteria.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attachment Loss, Periodontal, Teeth, Impacted
    Keywords
    third molar surgery, amelogenin, periodontal pocket

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    A randomized, split-mouth, placebo-controlled, single blind clinical trial, a pilot study
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    5 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    amelogenins group
    Arm Type
    Active Comparator
    Arm Description
    The study involved enrolling 5 periodontitis free patients, to which the extraction of both lower third molars was prescribed. A bone defect at the distal surface of the second molar ≥ 5 mm, had to be present on the intraoral periapical radiography, bilaterally. Amelogenins effect was evaluated by applying them only in the test site and comparing healing results with those obtained on the contra-lateral site
    Arm Title
    placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    The study involved enrolling 5 periodontitis free patients, to which the extraction of both lower third molars was prescribed. A bone defect at the distal surface of the second molar ≥ 5 mm, had to be present on the intraoral periapical radiography, bilaterally. In this group (control site) the conventional treatment was performed, and healing was ensured only by the simple blood clot
    Intervention Type
    Drug
    Intervention Name(s)
    Amelogenin
    Other Intervention Name(s)
    third molar surgery
    Intervention Description
    amelogenins applied on the distal surface of the lower second molar after adjacent third molar extraction
    Intervention Type
    Drug
    Intervention Name(s)
    Placebos
    Other Intervention Name(s)
    third molar surgery
    Intervention Description
    placebo applied on the distal surface of the lower second molar after adjacent third molar extraction
    Primary Outcome Measure Information:
    Title
    CAL (Clinical attachment level) pre operative
    Time Frame
    baseline, pre-surgery
    Title
    CAL (Clinical attachment level) post operative
    Time Frame
    7 days after surgery
    Title
    CAL (Clinical attachment level) 3 months
    Time Frame
    3 months after surgery.
    Title
    CAL (Clinical attachment level) 12 months
    Time Frame
    12 months after surgery.
    Title
    PPD (Periodontal probing dept) pre operative
    Time Frame
    baseline, pre-surgery
    Title
    PPD (Periodontal probing dept) post operative
    Time Frame
    7 days after surgery
    Title
    PPD (Periodontal probing dept) 3 months
    Time Frame
    3 months after surgery.
    Title
    PPD (Periodontal probing dept) 12 months
    Time Frame
    12 months after surgery.
    Title
    REC (recession) pre operative
    Time Frame
    baseline, pre-surgery
    Title
    REC (recession) post operative
    Time Frame
    7 days after surgery
    Title
    REC (recession) 3 months
    Time Frame
    3 months after surgery.
    Title
    REC (recession) 12 months
    Time Frame
    12 months after surgery.
    Title
    Radiographic bone Level pre operative
    Time Frame
    An endoral x-ray was taken baseline, pre-surgery
    Title
    Radiographic bone Level post operative
    Time Frame
    An endoral x-ray was taken 7 days after surgery
    Title
    Radiographic bone Level 3 months
    Time Frame
    An endoral x-ray was taken 3 months after surgery.
    Title
    Radiographic bone Level 12 months
    Time Frame
    An endoral x-ray was taken 12 months after surgery.
    Secondary Outcome Measure Information:
    Title
    Adverse Events pre operative
    Description
    the occurrence of adverse events after the use of amelogenins.
    Time Frame
    pre-operative
    Title
    Adverse Events post operative
    Description
    the occurrence of adverse events after the use of amelogenins.
    Time Frame
    7 days after surgery
    Title
    Adverse Events 3 months
    Description
    the occurrence of adverse events after the use of amelogenins.
    Time Frame
    3 months after surgery.
    Title
    Adverse Events 12 months
    Description
    the occurrence of adverse events after the use of amelogenins.
    Time Frame
    12 months after surgery.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    27 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients aged < 27, for which the extraction of both lower third molars was indicated Bilateral total (bone or osteo-mucosal) third molar impaction Bilateral bone defect ≥ 5mm distal to the lower second molars, evaluated on pre- operative periapical radiographs performed with Rinn's film holders PPD ≥ 8mm distal to the second lower molars, in at least one of the following probing sites: buccal, disto-buccal, disto-central, disto-lingual Intra-operative integrity of both third molar buccal and lingual alveolar cortices Exclusion Criteria: Smoking habit Systemic disorders with serious immunologic impairment Taking cortisone or other drugs that might interfere with healing process Allergy to penicillins Previous periodontal treatment Less than 2 mm of adherent gingiva at second molar level Second molars with a prosthetic crown Previous endodontic treatment of second molars Furcation involvement of the second molars
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Roberto Pippi, MDDS
    Organizational Affiliation
    University of Roma La Sapienza
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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