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Amnion-Chorion Allograft Barrier Used for Root Surface and Guided Tissue Regeneration for Periodontal Intrabony Defects and Grade II Furcation Defects.

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ClinicalTrials.gov Identifier: NCT03095976
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Yusuke Hamada, Indiana University

Brief Summary:
The purpose of this pilot project is to evaluate the efficacy of application of Amnion-Chorion allograft membrane on the root surface of periodontally diseased teeth in conjunction with bone substitute covered by Amnion-Chorion allograft in a combination GTR treatment of periodontal intrabony and furcation defects.

Condition or disease Intervention/treatment Phase
Periodontal Diseases Procedure: Amnion-Chorion allograft membrane on the root surface of periodontally diseased site. Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective Case Series
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Amnion-Chorion Allograft Barrier Used for Root Surface and Guided Tissue Regeneration for Periodontal Intrabony Defects and Grade II Furcation Defects.
Actual Study Start Date : June 14, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: Test group
Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects.
Procedure: Amnion-Chorion allograft membrane on the root surface of periodontally diseased site.
Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects




Primary Outcome Measures :
  1. Probing depth reduction. [ Time Frame: Six months after intervention. ]
    Probing depth will be measured at intrabony defect following surgical procedure.

  2. Clinical Attachment Gain [ Time Frame: Six months after intervention. ]
    Clinical Attachment is defined as the sum of probing depth and gingival recession. The amount of gain of attachment level will be measured.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. ASA class I or II;
  2. age >18 years old;
  3. Non-smoker;
  4. diagnosis of chronic or aggressive periodontitis previously treated with nonsurgical mechanical debridement; 5) patients have at least one two-wall intrabony defect in interproximal areas with radiographic evidence of an intrabony component of ≥ 4 mm, PPD ≥ 6 mm with 1-wall or 2-wall or combination of those defects;

6) Glickman Grade II furcation involvement on buccal of mandibular or maxillary first or second molars without soft tissue exposure of furcation entrance; 7) tooth mobility Miller Grade <1; 8) more than 2mm of keratinized tissue with those selected teeth.

Exclusion Criteria:

  1. did not meet all inclusion criteria;
  2. pregnancy or nursing woman;
  3. subjects with active systemic or localized infection (exclude chronic periodontitis);
  4. poor compliance or failure to maintain good oral hygiene as ascertained by the presence of full-mouth plaque score ≥ 20%;
  5. restorations or caries on root surfaces or untreated endodontic infections;
  6. participants received periodontal surgical treatment on the same site of this study within 2 years;
  7. use of systemic or local antibiotics on the anticipated surgical sites during the past 3 months.

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): NCT03095976


Contacts
Contact: Yusule Hamada, DDS, MSD 317-274-5121 yuhamada@iupui.edu

Locations
United States, Indiana
Indiana University School of Dentistry Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Yusuke Hamada, DDS, MSD    317-274-5121    yuhamada@iupui.edu   
Contact: Steven Blanchard, DDS, MS         
Sponsors and Collaborators
Indiana University

Publications:

Responsible Party: Yusuke Hamada, Clinical Assistant Professor, Indiana University
ClinicalTrials.gov Identifier: NCT03095976     History of Changes
Other Study ID Numbers: 1608175133
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 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: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Yusuke Hamada, Indiana University:
Guided Tissue Regeneration,
Amnion-Chorion,
Intrabony defects,
furcation

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Furcation Defects
Mouth Diseases
Stomatognathic Diseases