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

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ClinicalTrials.gov Identifier: NCT04675385
Recruitment Status : Completed
First Posted : December 19, 2020
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Nguyen Thu Thuy, University of Medicine and Pharmacy at Ho Chi Minh City

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis, Hyaluronic Acid Drug: 0.2% hyaluronic acid gel Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyaluronic Acid 0.2% Application Enhanced Chronic Periodontitis Treatment in Non-surgical Phase
Actual Study Start Date : June 21, 2019
Actual Primary Completion Date : September 21, 2019
Actual Study Completion Date : July 31, 2020

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Arms and Interventions
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Intervention Details:
  • Drug: 0.2% hyaluronic acid gel
    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.

Outcome Measures
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Primary Outcome Measures :
  1. Probing pocket depth (PPD) [ Time Frame: 6 weeks ]
    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.

  2. Plaque index (PlI) [ Time Frame: 6 weeks ]
    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.

  3. Gingival index (GI) [ Time Frame: 6 weeks ]
    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.

  4. Clinical attachment loss (CAL) [ Time Frame: 6 weeks ]
    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.

  5. Bleeding on probing (BOP) [ Time Frame: 6 weeks ]
    BOP was presented by the percentage of recorded bleeding sites.

  6. Copy number of Porphyromonas gingivalis (Pg) [ Time Frame: 6 weeks ]
    The copy number of Porphyromonas gingivalis (Pg) was monitored by Real-time PCR

  7. Copy number of Treponema denticola (Td) [ Time Frame: 6 weeks ]
    The copy number of Treponema denticola (Td) was monitored by Real-time PCR

  8. Copy number of Fusobacterium nucleatum (Fn) [ Time Frame: 6 weeks ]
    The copy number of Fusobacterium nucleatum (Fn) was monitored by Real-time PCR

  9. Copy number of Tannerella forsythia (Tf) [ Time Frame: 6 weeks ]
    The copy number of Tannerella forsythia (Tf) was monitored by Real-time PCR


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04675385


Locations
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Vietnam
Faculty of Odontostomatology - University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Vietnam, 749000
Sponsors and Collaborators
University of Medicine and Pharmacy at Ho Chi Minh City
Investigators
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Study Director: Thuy T Nguyen, PhD University of Medicine and Pharmacy at Ho Chi Minh City
More Information
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Publications:

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Responsible Party: Nguyen Thu Thuy, DDS, PhD, University of Medicine and Pharmacy at Ho Chi Minh City
ClinicalTrials.gov Identifier: NCT04675385    
Other Study ID Numbers: 1852/QD-DHYD
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Hyaluronic Acid
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents