Evaluation of the Efficacy of 0.8% Hyaluronic Acid Gel

Periodontitis Clinical Trial

Official title:

Clinical and Laboratory Effect of 0.8% Hyaluronic Acid Gel in Conventional Treatment of Moderate to Severe Chronic Periodontitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311906
• Other study ID #: FPGRP/43631003/73
• Status: Completed
• Phase: Phase 4
• First received: October 2, 2017
• Last updated: March 1, 2018
• Start date: February 15, 2017
• Est. completion date: October 2, 2017

Study information

• Verified date: March 2018
• Source: Riyadh Colleges of Dentistry and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Patients who fulfilled the selection criteria will be included in the study. One quadrant will be treated with HA gel (test) and the other without to serve as control. Clinical examination will be done in a dental chair under standard conditions of light, using mouth mirror and graduated Williams Periodontal Probe.

All patients will receive full mouth scaling and root planing with hand instruments and ultrasonic scalers at baseline. Thereafter, in the test quadrant, 1 ml of 0.8% hyaluronic acid gel will be administered subgingivally in all selected test sites at baseline and 1 week later. The following clinical parameters will be recorded at baseline, after 6 weeks and 12 weeks post treatment. Oral hygiene instructions will be given to all patients. The clinical measurements and treatment will be performed by a single examiner.For every patient and control subject, GCF samples will be collected at baseline, 6 weeks and 12 weeks post treatment. The samples will be pooled from two periodontal sites with clinical attachment level of 3 mm or more (in the two different quadrants). The sampling area will be isolated with cotton rolls and carefully will be cleaned supragingivally with sterile cotton pellets. A sterile absorbent paper point will be inserted into the gingival crevice or pocket until resistance will be felt. The paper point will be held in place for 30 s and then will be transferred to a vial containing 100 μL of distilled water and vigorously will be mixed. The paper points will be removed, and the samples will be centrifuged and will be washed twice with distilled water. The resultant pellets will be resuspended in 0.4 mL of distilled water. The samples will be coded and stored at −70 °C until use for ELISA test for identification of Human beta Defensin-2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2, 2017
• Est. primary completion date: August 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Drug:
• 0.8% Hyaluronic Acid
Application of 0.8% hyaluronic acid after scaling and root planing

Procedure:
• Scaling and Root Planing
Scaling of the teeth using hand and ultrasonic scalers followed by planing of the root with curettes

Locations

Country	Name	City	State
Saudi Arabia	Riyadh Colleges of Dentistry and Pharmacy	Riyadh	AlRiyadh

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Colleges of Dentistry and Pharmacy

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (22)

Brogden KA. Antimicrobial peptides: pore formers or metabolic inhibitors in bacteria? Nat Rev Microbiol. 2005 Mar;3(3):238-50. Review. — View Citation

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. — View Citation

Embery G, Waddington RJ, Hall RC, Last KS. Connective tissue elements as diagnostic aids in periodontology. Periodontol 2000. 2000 Oct;24:193-214. Review. — View Citation

García JR, Jaumann F, Schulz S, Krause A, Rodríguez-Jiménez J, Forssmann U, Adermann K, Klüver E, Vogelmeier C, Becker D, Hedrich R, Forssmann WG, Bals R. Identification of a novel, multifunctional beta-defensin (human beta-defensin 3) with specific antim — View Citation

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. — View Citation

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. Review. — View Citation

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

Haffajee AD, Socransky SS. Microbial etiological agents of destructive periodontal diseases. Periodontol 2000. 1994 Jun;5:78-111. Review. — View Citation

Heitz-Mayfield LJ. How effective is surgical therapy compared with nonsurgical debridement? Periodontol 2000. 2005;37:72-87. — View Citation

Jentsch H, Pomowski R, Kundt G, Göcke R. Treatment of gingivitis with hyaluronan. J Clin Periodontol. 2003 Feb;30(2):159-64. — View Citation

Johannsen A, Tellefsen M, Wikesjö 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. — View Citation

LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. — View Citation

Löe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. — View Citation

Moseley R, Waddington RJ, Embery G. Hyaluronan and its potential role in periodontal healing. Dent Update. 2002 Apr;29(3):144-8. — View Citation

Mühlemann HR. Psychological and chemical mediators of gingival health. J Prev Dent. 1977 Jul-Aug;4(4):6-17. — View Citation

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 — View Citation

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 ß-defensin-2 in saliva. J Periodontol. 2013 Oct;84(10):1445-53. doi: 10.1902/jop.2012.120321. — View Citation

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( — View Citation

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. — View Citation

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. 20 — View Citation

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. — View Citation

Xu Y, Höfling K, Fimmers R, Frentzen M, Jervøe-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 A — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Probing Depth change	It's the distance from the gingival margin to base of the sulcus	baseline, six weeks, 12 weeks
Primary	Gingival Index change (Loe and Silness, 1963)	To assess the gingival condition and record qualitative chances in the gingiva	baseline, six weeks, 12 weeks
Primary	Plaque index change (Loe and Silness, 1964)	To measure the state of oral hygiene	baseline, six weeks, 12 weeks
Primary	Papillary Bleeding Index change (Muhlemann, 1977)	immediate evaluation of the patient's gingival motivation and condition	baseline, six weeks, 12 weeks
Secondary	HBD-2 change	By take gingival crevicular fluid sample elisa test	baseline, six weeks, 12 weeks