Hyaluronic Acid Versus Red Injectable Platelet Rich Fibrin in Treatment of Periodontitis

NCT05768243 | Completed Phase 4

• 1 other identifier: 2019-H-0075-D-R-0293
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

the aim of this clinical trial is to compare the efficacy of hyaluronic acid (HA) used as an adjunctive to scaling and root planing (SRP) and red injectable platelet rich-fibrin (i-PRF) in the non-surgical treatment of stage III periodontitis. The main question it aims to answer is: is there a difference between HA and red i-prf when used as an adjunct to SRP in terms of efficacy? Participants who are eligible will be assigned to one of the treatment groups:

• Group 1= receives HA+ SRP
• Group 2= receives red i-prf + SRP
• Group 3= receives only SRP Researchers will compare Groups 1,2 and 3 to see if there's a difference in the periodontal parameters measured.

Conditions

Periodontitis Chronic Generalized Severe

Outcome Measures

Primary Outcomes (2)

• Clinical Attachment Level

  used to assess the loss of periodontal tissue support in periodontitis. It is the distance from the cemento-enamel junction (fixed point on the tooth) to the depth of the pocket

  4 weeks

• Probing Depth

  used to detect the depth of the periodontal pocket. It is the distance from the gingival margin to the base of the pocket.

  4 weeks

Secondary Outcomes (3)

• Bleeding on Probing

  4 weeks

• Plaque index

  4 weeks

• Gingival index

  4 weeks

Study Arms (3)

Treated with hyaluronic acid + SRP

EXPERIMENTAL

After scaling and root planing, hyaluronic acid (GENGIGEL®) will be applied in the following forms (one ml of 0.8% HA was injected subgingivally once every four weeks), topically (0.2 ml of 0.8% HA applied by the patient twice daily for the following 14 days after the subgingival application).

Drug: Hyaluronic acid

Treated with red i-PRF + SRP

EXPERIMENTAL

The red i-PRF will be injected into the pocket at the point of interdental space after SRP. Moreover, to control bleeding due to the needle tip after the procedure, a saline-soaked sponge will be placed between the lip and the gingiva and removed after 15 minutes. A total of four sessions of i-PRF will be administered to patients at a ten-day interval.

Procedure: red injectable platelet rich fibrin (i-prf)

Scaling and root planing only

NO INTERVENTION

no adjunctive treatment will be done to scaling and root planing

Interventions

Hyaluronic acid DRUG

hyaluronic acid is used as an adjunctive treatment to scaling and root planing

Also known as: GENGIGEL®

Treated with hyaluronic acid + SRP

red injectable platelet rich fibrin (i-prf) PROCEDURE

injecting red i-prf into the pocket after scaling and root planing

Treated with red i-PRF + SRP

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• clinical periodontal loss and radiographic bone loss of stage III/grades A and B with no history of systemic disease.
• at least four periodontal sites with a pocket depth of six mm or greater
• radiographic evidence of bone loss extending to the middle third of the root
• clinical attachment loss of five mm or more

You may not qualify if:

• uncontrolled systemic conditions (uncontrolled diabetes or uncontrolled hypertension)
• bleeding disorders, or on anticoagulant therapy
• alcohol users
• pregnant or lactating females
• heavy smokers (more than ten cigarettes per day)
• chemo or radio therapy
• antibiotic/anti-inflammatory drugs over the last three months before treatment.

Sponsors & Collaborators

• Beirut Arab University: lead

Study Sites (1)

Beirut Arab University

Beirut, Lebanon

Location

Related Publications (20)

• Dietrich T, Ower P, Tank M, West NX, Walter C, Needleman I, Hughes FJ, Wadia R, Milward MR, Hodge PJ, Chapple ILC; British Society of Periodontology. Periodontal diagnosis in the context of the 2017 classification system of periodontal diseases and conditions - implementation in clinical practice. Br Dent J. 2019 Jan 11;226(1):16-22. doi: 10.1038/sj.bdj.2019.3.

  PMID: 30631188 BACKGROUND

• Dahiya P, Kamal R. Hyaluronic Acid: a boon in periodontal therapy. N Am J Med Sci. 2013 May;5(5):309-15. doi: 10.4103/1947-2714.112473.

  PMID: 23814761 BACKGROUND

• Sanz I, Alonso B, Carasol M, Herrera D, Sanz M. Nonsurgical treatment of periodontitis. J Evid Based Dent Pract. 2012 Sep;12(3 Suppl):76-86. doi: 10.1016/S1532-3382(12)70019-2.

  PMID: 23040340 BACKGROUND

• Casale M, Moffa A, Vella P, Sabatino L, Capuano F, Salvinelli B, Lopez MA, Carinci F, Salvinelli F. Hyaluronic acid: Perspectives in dentistry. A systematic review. Int J Immunopathol Pharmacol. 2016 Dec;29(4):572-582. doi: 10.1177/0394632016652906. Epub 2016 Jun 8.

  PMID: 27280412 BACKGROUND

• Hakkinen L, Uitto VJ, Larjava H. Cell biology of gingival wound healing. Periodontol 2000. 2000 Oct;24:127-52. No abstract available.

  PMID: 11276865 BACKGROUND

• Kour P, Pudakalkatti PS, Vas AM, Das S, Padmanabhan S. Comparative Evaluation of Antimicrobial Efficacy of Platelet-rich Plasma, Platelet-rich Fibrin, and Injectable Platelet-rich Fibrin on the Standard Strains of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans. Contemp Clin Dent. 2018 Sep;9(Suppl 2):S325-S330. doi: 10.4103/ccd.ccd_367_18.

  PMID: 30294166 BACKGROUND

• Thanasrisuebwong P, Kiattavorncharoen S, Surarit R, Phruksaniyom C, Ruangsawasdi N. Red and Yellow Injectable Platelet-Rich Fibrin Demonstrated Differential Effects on Periodontal Ligament Stem Cell Proliferation, Migration, and Osteogenic Differentiation. Int J Mol Sci. 2020 Jul 21;21(14):5153. doi: 10.3390/ijms21145153.

  PMID: 32708242 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Aydinyurt HS, Akbal D, Altindal D, Bozoglan A, Ertugrul AS, Demir H. Evaluation of biochemical and clinical effects of hyaluronic acid on non-surgical periodontal treatment: a randomized controlled trial. Ir J Med Sci. 2020 Nov;189(4):1485-1494. doi: 10.1007/s11845-020-02230-6. Epub 2020 May 21.

  PMID: 32436173 BACKGROUND

• Vanden Bogaerde L. Treatment of infrabony periodontal defects with esterified hyaluronic acid: clinical report of 19 consecutive lesions. Int J Periodontics Restorative Dent. 2009 Jun;29(3):315-23.

  PMID: 19537471 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Karakostas P, Davidopoulou S, Kalfas S. Use of Hyaluronic Acid in Periodontal Disease Treatment: A Systematic Review. J Contemp Dent Pract. 2022 Mar 1;23(3):355-370.

  PMID: 35781443 BACKGROUND

• Olszewska-Czyz I, Kralik K, Tota M, Prpic J. The Influence of Hyaluronic Acid Adjunctive Therapy of Periodontitis on Salivary Markers of Oxidative Stress: Randomized, Controlled Clinical Trial. Antioxidants (Basel). 2022 Jan 7;11(1):135. doi: 10.3390/antiox11010135.

  PMID: 35052639 BACKGROUND

• Yan Y, Zhan Y, Wang X, Hou J. Clinical evaluation of ultrasonic subgingival debridement versus ultrasonic subgingival scaling combined with manual root planing in the treatment of periodontitis: study protocol for a randomized controlled trial. Trials. 2020 Jan 28;21(1):113. doi: 10.1186/s13063-019-4031-y.

  PMID: 31992331 BACKGROUND

• Zijnge V, Meijer HF, Lie MA, Tromp JA, Degener JE, Harmsen HJ, Abbas F. The recolonization hypothesis in a full-mouth or multiple-session treatment protocol: a blinded, randomized clinical trial. J Clin Periodontol. 2010 Jun;37(6):518-25. doi: 10.1111/j.1600-051X.2010.01562.x.

  PMID: 20507375 BACKGROUND

• Wang X, Zhang Y, Choukroun J, Ghanaati S, Miron RJ. Behavior of Gingival Fibroblasts on Titanium Implant Surfaces in Combination with either Injectable-PRF or PRP. Int J Mol Sci. 2017 Feb 4;18(2):331. doi: 10.3390/ijms18020331.

  PMID: 28165420 BACKGROUND

• Thanasrisuebwong P, Surarit R, Bencharit S, Ruangsawasdi N. Influence of Fractionation Methods on Physical and Biological Properties of Injectable Platelet-Rich Fibrin: An Exploratory Study. Int J Mol Sci. 2019 Apr 3;20(7):1657. doi: 10.3390/ijms20071657.

  PMID: 30987117 BACKGROUND

• Fang H, Han M, Li QL, Cao CY, Xia R, Zhang ZH. Comparison of full-mouth disinfection and quadrant-wise scaling in the treatment of adult chronic periodontitis: a systematic review and meta-analysis. J Periodontal Res. 2016 Aug;51(4):417-30. doi: 10.1111/jre.12326. Epub 2015 Oct 19.

  PMID: 26477533 BACKGROUND

Related Links

• accepted paper (yet not published in a journal)

MeSH Terms

Interventions

Hyaluronic Acid; proliferation regulatory factors, human urine

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Nayer Aboelsaad, PhD

  Professor and Chairman of Periodontology department - BeirutArabU

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 14, 2023
• Study Start: March 1, 2021
• Primary Completion: July 24, 2022
• Study Completion: September 17, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)