Evaluation of the Efficacy of 0.8% Hyaluronic Acid Gel

NCT03311906 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: FPGRP/43631003/73
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

assess the clinical and laboratory effects of the local and sub gingival application of a 0.8% hyaluronic acid gel (GENGIGEL®) as an adjunct to scaling and root planning (SRP) in chronic moderate to severe periodontitis patients as indicated by expression of Human Beta Definsin-2 (HBD2) in gingival crevicular fluid (GCF).

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (5)

• Clinical Attachment Level (CAL) change

  Distance from the cementoenamel junction to the base of gingival sulcus using a UNC15 probe

  baseline, six weeks, 12 weeks

• Probing Depth change

  It's the distance from the gingival margin to base of the sulcus

  baseline, six weeks, 12 weeks

• Gingival Index change (Loe and Silness, 1963)

  To assess the gingival condition and record qualitative chances in the gingiva

  baseline, six weeks, 12 weeks

• Plaque index change (Loe and Silness, 1964)

  To measure the state of oral hygiene

  baseline, six weeks, 12 weeks

• Papillary Bleeding Index change (Muhlemann, 1977)

  immediate evaluation of the patient's gingival motivation and condition

  baseline, six weeks, 12 weeks

Secondary Outcomes (1)

• HBD-2 change

  baseline, six weeks, 12 weeks

Study Arms (2)

Test side

EXPERIMENTAL

Scaling and Root Planing 0.8% Hyaluronic acid gel

Drug: 0.8% Hyaluronic Acid; Procedure: Scaling and Root Planing

Control Side

ACTIVE COMPARATOR

Scaling and Root Planing

Procedure: Scaling and Root Planing

Interventions

0.8% Hyaluronic Acid DRUG

Application of 0.8% hyaluronic acid after scaling and root planing

Also known as: Gengigel

Test side

Scaling and Root Planing PROCEDURE

Scaling of the teeth using hand and ultrasonic scalers followed by planing of the root with curettes

Control Side; Test side

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients should be systemically healthy with moderate to severe chronic periodontitis of more than 4 mm probing depth in at least two sites in different quadrants.
• Patient should exhibit no known allergies
• Participants should have the ability to attend the hospital regular intervals.

You may not qualify if:

• pregnancy
• nursing
• hypertension
• patient with chronic diseases such as diabetes mellitus or rheumatoid arthritis. -Participants should not be under antibiotics and\\or had receive any periodontal therapy for the last 6 months.
• Participants should not taking drugs that could affect the state of the gingival tissues.
• Participants must not be undergoing orthodontic therapy, caries free
• Participants must not be using any other supplemental plaque control measures like mouthwashes.
• Participants should not have the habit of taking alcohol, smoking or chewing tobacco and do not suffer from any systemic disease.

Sponsors & Collaborators

• Riyadh Colleges of Dentistry and Pharmacy: lead

Study Sites (1)

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, AlRiyadh, 11681, Saudi Arabia

Location

Related Publications (22)

• Brogden KA. Antimicrobial peptides: pore formers or metabolic inhibitors in bacteria? Nat Rev Microbiol. 2005 Mar;3(3):238-50. doi: 10.1038/nrmicro1098.

  PMID: 15703760 RESULT

• Diamond DL, Kimball JR, Krisanaprakornkit S, Ganz T, Dale BA. Detection of beta-defensins secreted by human oral epithelial cells. J Immunol Methods. 2001 Oct 1;256(1-2):65-76. doi: 10.1016/s0022-1759(01)00442-2.

  PMID: 11516756 RESULT

• Embery G, Waddington RJ, Hall RC, Last KS. Connective tissue elements as diagnostic aids in periodontology. Periodontol 2000. 2000 Oct;24:193-214. doi: 10.1034/j.1600-0757.2000.2240109.x. No abstract available.

  PMID: 11276867 RESULT

• Garcia JR, Jaumann F, Schulz S, Krause A, Rodriguez-Jimenez J, Forssmann U, Adermann K, Kluver E, Vogelmeier C, Becker D, Hedrich R, Forssmann WG, Bals R. Identification of a novel, multifunctional beta-defensin (human beta-defensin 3) with specific antimicrobial activity. Its interaction with plasma membranes of Xenopus oocytes and the induction of macrophage chemoattraction. Cell Tissue Res. 2001 Nov;306(2):257-64. doi: 10.1007/s004410100433.

  PMID: 11702237 RESULT

• Gontiya G, Galgali SR. Effect of hyaluronan on periodontitis: A clinical and histological study. J Indian Soc Periodontol. 2012 Apr;16(2):184-92. doi: 10.4103/0972-124X.99260.

  PMID: 23055583 RESULT

• Gorr SU. Antimicrobial peptides in periodontal innate defense. Front Oral Biol. 2012;15:84-98. doi: 10.1159/000329673. Epub 2011 Nov 11.

  PMID: 22142958 RESULT

• Gorr SU, Abdolhosseini M. Antimicrobial peptides and periodontal disease. J Clin Periodontol. 2011 Mar;38 Suppl 11:126-41. doi: 10.1111/j.1600-051X.2010.01664.x.

  PMID: 21323710 RESULT

• Haffajee AD, Socransky SS. Microbial etiological agents of destructive periodontal diseases. Periodontol 2000. 1994 Jun;5:78-111. doi: 10.1111/j.1600-0757.1994.tb00020.x. No abstract available.

  PMID: 9673164 RESULT

• Heitz-Mayfield LJ. How effective is surgical therapy compared with nonsurgical debridement? Periodontol 2000. 2005;37:72-87. doi: 10.1111/j.1600-0757.2004.03797.x. No abstract available.

  PMID: 15655026 RESULT

• Jentsch H, Pomowski R, Kundt G, Gocke R. Treatment of gingivitis with hyaluronan. J Clin Periodontol. 2003 Feb;30(2):159-64. doi: 10.1034/j.1600-051x.2003.300203.x.

  PMID: 12622859 RESULT

• Johannsen A, Tellefsen M, Wikesjo U, Johannsen G. Local delivery of hyaluronan as an adjunct to scaling and root planing in the treatment of chronic periodontitis. J Periodontol. 2009 Sep;80(9):1493-7. doi: 10.1902/jop.2009.090128.

  PMID: 19722800 RESULT

• Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.

  PMID: 5237684 RESULT

• LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

  PMID: 14121956 RESULT

• Moseley R, Waddington RJ, Embery G. Hyaluronan and its potential role in periodontal healing. Dent Update. 2002 Apr;29(3):144-8. doi: 10.12968/denu.2002.29.3.144.

  PMID: 11989392 RESULT

• Muhlemann HR. Psychological and chemical mediators of gingival health. J Prev Dent. 1977 Jul-Aug;4(4):6-17. No abstract available.

  PMID: 275483 RESULT

• Niyonsaba F, Ushio H, Nakano N, Ng W, Sayama K, Hashimoto K, Nagaoka I, Okumura K, Ogawa H. Antimicrobial peptides human beta-defensins stimulate epidermal keratinocyte migration, proliferation and production of proinflammatory cytokines and chemokines. J Invest Dermatol. 2007 Mar;127(3):594-604. doi: 10.1038/sj.jid.5700599. Epub 2006 Oct 19.

  PMID: 17068477 RESULT

• Pereira AL, Franco GC, Cortelli SC, Aquino DR, Costa FO, Raslan SA, Cortelli JR. Influence of periodontal status and periodontopathogens on levels of oral human beta-defensin-2 in saliva. J Periodontol. 2013 Oct;84(10):1445-53. doi: 10.1902/jop.2012.120321. Epub 2012 Nov 23.

  PMID: 23173827 RESULT

• Pilloni A, Annibali S, Dominici F, Di Paolo C, Papa M, Cassini MA, Polimeni A. Evaluation of the efficacy of an hyaluronic acid-based biogel on periodontal clinical parameters. A randomized-controlled clinical pilot study. Ann Stomatol (Roma). 2011 Mar;2(3-4):3-9. Epub 2012 Jan 27.

  PMID: 22545183 RESULT

• Pirnazar P, Wolinsky L, Nachnani S, Haake S, Pilloni A, Bernard GW. Bacteriostatic effects of hyaluronic acid. J Periodontol. 1999 Apr;70(4):370-4. doi: 10.1902/jop.1999.70.4.370.

  PMID: 10328647 RESULT

• Polepalle T, Srinivas M, Swamy N, Aluru S, Chakrapani S, Chowdary BA. Local delivery of hyaluronan 0.8% as an adjunct to scaling and root planing in the treatment of chronic periodontitis: A clinical and microbiological study. J Indian Soc Periodontol. 2015 Jan-Feb;19(1):37-42. doi: 10.4103/0972-124X.145807.

  PMID: 25810591 RESULT

• Porter EM, Liu L, Oren A, Anton PA, Ganz T. Localization of human intestinal defensin 5 in Paneth cell granules. Infect Immun. 1997 Jun;65(6):2389-95. doi: 10.1128/iai.65.6.2389-2395.1997.

  PMID: 9169779 RESULT

• Xu Y, Hofling K, Fimmers R, Frentzen M, Jervoe-Storm PM. Clinical and microbiological effects of topical subgingival application of hyaluronic acid gel adjunctive to scaling and root planing in the treatment of chronic periodontitis. J Periodontol. 2004 Aug;75(8):1114-8. doi: 10.1902/jop.2004.75.8.1114.

  PMID: 15455740 RESULT

MeSH Terms

Conditions

Periodontitis

Interventions

Hyaluronic Acid; Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Sanaa M Shafshak, PhD

  Riyadh Colleges of Dentistry and Pharmacy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident

Model Details: A split mouth study design is used where all participants receive both interventions

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 17, 2017
• Study Start: February 15, 2017
• Primary Completion: August 15, 2017
• Study Completion: October 2, 2017
• Last Updated: March 5, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)