Hyaluronic Acid 0.2% Application Enhanced Chronic Periodontitis Treatment in Non-surgical Phase

NCT04675385 | Completed Phase 4 FDA Drug

• 1 other identifier: 1852/QD-DHYD
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Chronic periodontitis is one of the most common causes of tooth loss and is rather common in the population. Treating chronic periodontitis remains a challenge for dental practitioners. The purpose of this study was to assess the clinical effects of sub-gingival application of 0.2% hyaluronic acid gel after root planing in the treatment of chronic periodontitis. Materials and Methods: In this split mouth study, 733 periodontal pockets of 28 patients with moderate to severe chronic periodontitis were chosen for investigation. They were divided into 2 groups: control group and experimental group. The experimental group received sub-gingival administration of 1 ml of 0.2% hyaluronic acid gel into each pocket immediately after root planing and then after 1 week, 2 weeks and 3 weeks. Clinical parameters were assessed at baseline and 6 weeks after root planing. Subgingival plaque was assessed at baseline and 6 weeks after root planing. Quantitative real-time PCR for Porphyromonas gingivalis (Pg), Treponema denticola (Td), Fusobacterium nucleatum (Fn) Tannerella forsythia (Tf) were performed at the same time.

Conditions

Chronic Periodontitis, Hyaluronic Acid

Outcome Measures

Primary Outcomes (9)

• Probing pocket depth (PPD)

  Periodontal pocket depth was evaluated at six positions in all teeth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual). The value of PPD was calculated by the total score/the number of positions.

  6 weeks

• Plaque index (PlI)

  Plaque index (PlI) was evaluated at six positions in all teeth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual). The value of PlI was calculated by the total score/the number of positions.

  6 weeks

• Gingival index (GI)

  Gingival index (GI) was evaluated at six positions in all teeth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual). The value of GI was calculated by the total score/the number of positions.

  6 weeks

• Clinical attachment loss (CAL)

  Clinical attachment loss (CAL) was evaluated at six positions in all teeth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual). The value of CAL was calculated by the total score/the number of positions.

  6 weeks

• Bleeding on probing (BOP)

  BOP was presented by the percentage of recorded bleeding sites.

  6 weeks

• Copy number of Porphyromonas gingivalis (Pg)

  The copy number of Porphyromonas gingivalis (Pg) was monitored by Real-time PCR

  6 weeks

• Copy number of Treponema denticola (Td)

  The copy number of Treponema denticola (Td) was monitored by Real-time PCR

  6 weeks

• Copy number of Fusobacterium nucleatum (Fn)

  The copy number of Fusobacterium nucleatum (Fn) was monitored by Real-time PCR

  6 weeks

• Copy number of Tannerella forsythia (Tf)

  The copy number of Tannerella forsythia (Tf) was monitored by Real-time PCR

  6 weeks

Interventions

0.2% hyaluronic acid gel DRUG

In this split mouth study, 733 periodontal pockets of 28 patients with moderate to severe chronic periodontitis were chosen for investigation. They were divided into 2 groups: control group and experimental group. The experimental group received sub-gingival administration of 1 ml of 0.2% hyaluronic acid gel into each pocket immediately after root planing and then after 1 week, 2 weeks and 3 weeks. Clinical parameters were assessed at baseline and 6 weeks after root planing. Subgingival plaque was assessed at baseline and 6 weeks after root planing. Quantitative real-time PCR for Porphyromonas gingivalis (Pg), Treponema denticola (Td), Fusobacterium nucleatum (Fn) Tannerella forsythia (Tf) were performed at the same time.

Eligibility Criteria

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

You may qualify if:

• Patients with at least 3 teeth in the contralateral quadrants diagnosed with moderate or severe chronic periodontitis according to AAP (2015): gingival bleeding at examination, ≥5mm periodontal pocket depth, bone resorption on X-ray film ≥16% or \>3mm root length.

You may not qualify if:

• Patients who were allergic to ingredients, being pregnant/lactating, smoking, alcoholic; who had undergone periodontal therapy in the last 6 months, received antibiotic therapy, anti-inflammatory agents, statins, drug induced gingival enlargement (such as phenytoin, cyclosporin, nifedipine) in the last 3 months

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Faculty of Odontostomatology - University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, 749000, Vietnam

Location

Related Publications (8)

• Al-Shammari NM, Shafshak SM, Ali MS. Effect of 0.8% Hyaluronic Acid in Conventional Treatment of Moderate to Severe Chronic Periodontitis. J Contemp Dent Pract. 2018 May 1;19(5):527-534.

  PMID: 29807962 BACKGROUND

• American Academy of Periodontology Task Force Report on the Update to the 1999 Classification of Periodontal Diseases and Conditions. J Periodontol. 2015 Jul;86(7):835-8. doi: 10.1902/jop.2015.157001. Epub 2015 May 27. No abstract available.

  PMID: 26125117 BACKGROUND

• Bertl K, Bruckmann C, Isberg PE, Klinge B, Gotfredsen K, Stavropoulos A. Hyaluronan in non-surgical and surgical periodontal therapy: a systematic review. J Clin Periodontol. 2015 Mar;42(3):236-46. doi: 10.1111/jcpe.12371. Epub 2015 Mar 9.

  PMID: 25640222 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

• Eliezer M, Imber JC, Sculean A, Pandis N, Teich S. Hyaluronic acid as adjunctive to non-surgical and surgical periodontal therapy: a systematic review and meta-analysis. Clin Oral Investig. 2019 Sep;23(9):3423-3435. doi: 10.1007/s00784-019-03012-w. Epub 2019 Jul 23.

  PMID: 31338632 BACKGROUND

• Gohler A, Hetzer A, Holtfreter B, Geisel MH, Schmidt CO, Steinmetz I, Kocher T. Quantitative molecular detection of putative periodontal pathogens in clinically healthy and periodontally diseased subjects. PLoS One. 2014 Jul 16;9(7):e99244. doi: 10.1371/journal.pone.0099244. eCollection 2014.

  PMID: 25029268 BACKGROUND

• Rafiei M, Kiani F, Sayehmiri F, Sayehmiri K, Sheikhi A, Zamanian Azodi M. Study of Porphyromonas gingivalis in periodontal diseases: A systematic review and meta-analysis. Med J Islam Repub Iran. 2017 Sep 12;31:62. doi: 10.18869/mjiri.31.62. eCollection 2017.

  PMID: 29445691 BACKGROUND

• Van der Weijden GAF, Dekkers GJ, Slot DE. Success of non-surgical periodontal therapy in adult periodontitis patients: A retrospective analysis. Int J Dent Hyg. 2019 Nov;17(4):309-317. doi: 10.1111/idh.12399. Epub 2019 May 16.

  PMID: 30942938 BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thuy T Nguyen, PhD

  University of Medicine and Pharmacy at Ho Chi Minh City

  STUDY DIRECTOR

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: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD

Model Details: Participants from 18 years old with a minimum number of 20 teeth who came for periodontitis treatment, were recruited at the Department of Periodontology, Faculty of Odonto-Stomalogy, the University of Medicine and Pharmacy at Ho Chi Minh City (FOS-UMPH.

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 19, 2020
• Study Start: June 21, 2019
• Primary Completion: September 21, 2019
• Study Completion: July 31, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)