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

December 14, 2020 updated by: Nguyen Thu Thuy, University of Medicine and Pharmacy at Ho Chi Minh City

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. There are new applications of materials to promote the healing process and increase the effectiveness of treatment of CP such as antimicrobial and healing support agents which were used at scaling and root planing (SRP) phase with the desire to improve the effectiveness of treatment and reduce the frequency of surgical phase, in order to reduce treatment cost for patients. One of those materials is hyaluronic acid (HA).

HA is a polysaccharide with many important roles: maintaining stability, adjusting the viscosity of biological fluids, homeostasis, adjusting osmotic pressure, supporting structures ... The wide application of HA in medicine is due to its capability of binding multiple water molecules, bimproving tissue hydration and preventing mechanical damage, bacteriostatic, anti-inflamatory, osteoinductive.

This study was the first to be conducted in Vietnam to evaluate the effect of HA on the response of periodontal tissue in chronic periodontitis and its bactericidal efficiency. The bacteria we study were Porphyromonas gingivalis (Pg), Treponema denticola (Td), Fusobacterium nucleatum (Fn) Tannerella forsythia (Tf), which were important species in periodontitis development. The research results can supplement scientific evidence about the effects of this compound and clarify the usefulness of HA in clinical chronic periodontitis treatment.

We performed a randomized, controlled clinical trial with split-mouth design. Study procedure consisted of information collecting, clinical measurements and, data analysis. The study was conducted in full accordance with the World Medical Association Declaration of Helsinki 2000 and was registered at ClinicalTrials.gov No. 312/ĐHYD-HĐĐĐ.

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). We selected 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.

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 were excluded. We also excluded patients with systemic diseases such as cardiovascular disease, hypertension, diabetes mellitus, or orthodontic treatment and patients who refused to participate in the study and/or follow-up visits.

According to Rajan (2014), to obtain the difference of probing pocket depth (PPD) of 2 groups (control and HA), we got and were the average PPD and 1.38 and were standard deviation of two groups, respectively. With α = 0.05 and β = 0.2, we calculated N = 25. 28 subjects were enrolled to prevent sample loss.

Masking of control and HA treatment were applied to patients, the periodontist and outcome assessing investigators for all clinical and laboratory parameters. Only an independent investigator who applied HA knew the name of the drug due to the nature of the study. Another investigator who performed the statistical assignment phase was to all patient information and to the following analysis and evaluation of the data.

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. Wilcoxon sign-rank test and Mann-Whitney test were used for comparison of means.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 749000
        • Faculty of Odontostomatology - University of Medicine and Pharmacy at Ho Chi Minh City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
Bleeding on probing (BOP)
Time Frame: 6 weeks
BOP was presented by the percentage of recorded bleeding sites.
6 weeks
Copy number of Porphyromonas gingivalis (Pg)
Time Frame: 6 weeks
The copy number of Porphyromonas gingivalis (Pg) was monitored by Real-time PCR
6 weeks
Copy number of Treponema denticola (Td)
Time Frame: 6 weeks
The copy number of Treponema denticola (Td) was monitored by Real-time PCR
6 weeks
Copy number of Fusobacterium nucleatum (Fn)
Time Frame: 6 weeks
The copy number of Fusobacterium nucleatum (Fn) was monitored by Real-time PCR
6 weeks
Copy number of Tannerella forsythia (Tf)
Time Frame: 6 weeks
The copy number of Tannerella forsythia (Tf) was monitored by Real-time PCR
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Investigators

  • Study Director: Thuy T Nguyen, PhD, University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 21, 2019

Primary Completion (ACTUAL)

September 21, 2019

Study Completion (ACTUAL)

July 31, 2020

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 14, 2020

First Posted (ACTUAL)

December 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 14, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1852/QD-DHYD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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