Amnion-Chorion Allograft Barrier Used for Root Surface and Guided Tissue Regeneration

NCT03095976 | Completed Results DMC

• 1 other identifier: 1608175133
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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 Guided Tissue Regeneration (GTR) treatment of periodontal intrabony and furcation defects.

Conditions

Periodontal Diseases

Keywords

Guided Tissue Regeneration,; Amnion-Chorion,; Intrabony defects,; furcation

Outcome Measures

Primary Outcomes (2)

• Probing Depth Change

  Probing depth was measured at intrabony defect following surgical procedure.

  Baseline and 6 months

• Clinical Attachment Change

  Clinical Attachment is defined as the sum of probing depth and gingival recession. The amount of gain of attachment level will be measured.

  Baseline and 6 months

Study Arms (1)

Test group

EXPERIMENTAL

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.

Interventions

Amnion-Chorion allograft membrane on the root surface of periodontally diseased site. PROCEDURE

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

Test group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA class I or II;
• age \>18 years old;
• Non-smoker;
• 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;
• \) 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.

You may not qualify if:

• pregnancy or nursing woman;
• subjects with active systemic or localized infection (exclude chronic periodontitis);
• poor compliance or failure to maintain good oral hygiene as ascertained by the presence of full-mouth plaque score ≥ 20%;
• restorations or caries on root surfaces or untreated endodontic infections;
• participants received periodontal surgical treatment on the same site of this study within 2 years;
• use of systemic or local antibiotics on the anticipated surgical sites during the past 3 months.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

Related Publications (16)

• Eke PI, Dye BA, Wei L, Thornton-Evans GO, Genco RJ; CDC Periodontal Disease Surveillance workgroup: James Beck (University of North Carolina, Chapel Hill, USA), Gordon Douglass (Past President, American Academy of Periodontology), Roy Page (University of Washin. Prevalence of periodontitis in adults in the United States: 2009 and 2010. J Dent Res. 2012 Oct;91(10):914-20. doi: 10.1177/0022034512457373. Epub 2012 Aug 30.

  PMID: 22935673 BACKGROUND

• Bowers GM, Schallhorn RG, McClain PK, Morrison GM, Morgan R, Reynolds MA. Factors influencing the outcome of regenerative therapy in mandibular Class II furcations: Part I. J Periodontol. 2003 Sep;74(9):1255-68. doi: 10.1902/jop.2003.74.9.1255.

  PMID: 14584858 BACKGROUND

• Eickholz P, Horr T, Klein F, Hassfeld S, Kim TS. Radiographic parameters for prognosis of periodontal healing of infrabony defects: two different definitions of defect depth. J Periodontol. 2004 Mar;75(3):399-407. doi: 10.1902/jop.2004.75.3.399.

  PMID: 15088878 BACKGROUND

• Crea A, Deli G, Littarru C, Lajolo C, Orgeas GV, Tatakis DN. Intrabony defects, open-flap debridement, and decortication: a randomized clinical trial. J Periodontol. 2014 Jan;85(1):34-42. doi: 10.1902/jop.2013.120753. Epub 2013 Mar 28.

  PMID: 23537123 BACKGROUND

• Kiany F, Moloudi F. Amnion membrane as a novel barrier in the treatment of intrabony defects: a controlled clinical trial. Int J Oral Maxillofac Implants. 2015 May-Jun;30(3):639-47. doi: 10.11607/jomi.3590.

  PMID: 26009915 BACKGROUND

• Koob TJ, Rennert R, Zabek N, Massee M, Lim JJ, Temenoff JS, Li WW, Gurtner G. Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J. 2013 Oct;10(5):493-500. doi: 10.1111/iwj.12140. Epub 2013 Aug 1.

  PMID: 23902526 BACKGROUND

• Koob TJ, Lim JJ, Massee M, Zabek N, Rennert R, Gurtner G, Li WW. Angiogenic properties of dehydrated human amnion/chorion allografts: therapeutic potential for soft tissue repair and regeneration. Vasc Cell. 2014 May 1;6:10. doi: 10.1186/2045-824X-6-10. eCollection 2014.

  PMID: 24817999 BACKGROUND

• Chakraborthy S, Sambashivaiah S, Kulal R, Bilchodmath S. Amnion and Chorion Allografts in Combination with Coronally Advanced Flap in the Treatment of Gingival Recession: A Clinical Study. J Clin Diagn Res. 2015 Sep;9(9):ZC98-ZC101. doi: 10.7860/JCDR/2015/12971.6572. Epub 2015 Sep 1.

  PMID: 26501023 BACKGROUND

• Avila-Ortiz G, De Buitrago JG, Reddy MS. Periodontal regeneration - furcation defects: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S108-30. doi: 10.1902/jop.2015.130677.

  PMID: 25644295 BACKGROUND

• Albandar JM, Brown LJ, Loe H. Clinical features of early-onset periodontitis. J Am Dent Assoc. 1997 Oct;128(10):1393-9. doi: 10.14219/jada.archive.1997.0058.

  PMID: 9332140 BACKGROUND

• Genco RJ, Borgnakke WS. Risk factors for periodontal disease. Periodontol 2000. 2013 Jun;62(1):59-94. doi: 10.1111/j.1600-0757.2012.00457.x.

  PMID: 23574464 BACKGROUND

• Preshaw PM. Host response modulation in periodontics. Periodontol 2000. 2008;48:92-110. doi: 10.1111/j.1600-0757.2008.00252.x. No abstract available.

  PMID: 18715360 BACKGROUND

• Waerhaug J. The infrabony pocket and its relationship to trauma from occlusion and subgingival plaque. J Periodontol. 1979 Jul;50(7):355-65. doi: 10.1902/jop.1979.50.7.355.

  PMID: 381633 BACKGROUND

• Laurell L, Gottlow J, Zybutz M, Persson R. Treatment of intrabony defects by different surgical procedures. A literature review. J Periodontol. 1998 Mar;69(3):303-13. doi: 10.1902/jop.1998.69.3.303.

  PMID: 9579616 BACKGROUND

• Ivanovic A, Nikou G, Miron RJ, Nikolidakis D, Sculean A. Which biomaterials may promote periodontal regeneration in intrabony periodontal defects? A systematic review of preclinical studies. Quintessence Int. 2014 May;45(5):385-95. doi: 10.3290/j.qi.a31538.

  PMID: 24634903 BACKGROUND

• Claffey N, Egelberg J. Clinical characteristics of periodontal sites with probing attachment loss following initial periodontal treatment. J Clin Periodontol. 1994 Nov;21(10):670-9. doi: 10.1111/j.1600-051x.1994.tb00785.x.

  PMID: 7852611 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Yusuke Hamada
• Organization: Indiana University School of Dentistry

yuhamada@iupui.edu

317-274-5121

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Prospective Case Series

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: March 30, 2017
• Study Start: June 14, 2017
• Primary Completion: September 10, 2019
• Study Completion: September 10, 2019
• Last Updated: April 14, 2021
• Results First Posted: April 14, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)