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Study on Valaciclovir for Treating Advanced Gum Disease in Adults

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What is this study about?

This clinical trial is focused on studying the effects of an antiviral drug called Valaciclovir in treating a condition known as generalized periodontitis. Generalized periodontitis is a serious gum disease that affects the tissues surrounding the teeth, leading to inflammation and potential tooth loss. The study aims to compare the effectiveness of Valaciclovir combined with standard non-surgical treatments, such as scaling and root surfacing, against the same standard treatments with a placebo. The goal is to determine if adding Valaciclovir can improve treatment outcomes for patients with this gum disease.

Participants in the study will receive either the antiviral drug Valaciclovir or a placebo, along with conventional treatments for their gum disease. The study will last for a period of 28 days, during which the effects of the treatments will be closely monitored. After the treatment period, there will be a follow-up visit two months later to evaluate the condition of the gums and the overall effectiveness of the treatment. This evaluation will help determine if the addition of Valaciclovir provides any significant benefits over the standard treatment alone.

The study is designed to be prospective, randomized, and double-blind, meaning that neither the participants nor the researchers will know who is receiving the actual drug or the placebo during the trial. This approach helps ensure that the results are unbiased and reliable. The findings from this study could potentially lead to improved treatment strategies for individuals suffering from generalized periodontitis, offering them better management of their condition and possibly preventing further complications.

1 initial visit and consent

Upon joining the clinical trial, you will attend an initial visit where the study will be explained in detail. You will be required to sign an informed consent form, confirming your understanding and willingness to participate.

During this visit, your eligibility will be confirmed based on criteria such as age (18 years or older) and a diagnosis of generalized periodontitis (stage III or IV and grade A, B or C).

2 baseline assessment

A comprehensive assessment of your oral health will be conducted. This includes measuring the depth of periodontal pockets using a special probe.

Other clinical indices such as bleeding on probing, plaque index, and clinical attachment level will also be recorded.

3 medication administration

You will be randomly assigned to receive either the antiviral medication valaciclovir or a placebo. The medication is in the form of a film-coated tablet and is taken orally.

The dosage and frequency of administration will be provided by the study team, and you will be required to follow this regimen for the duration specified by the trial protocol.

4 non-surgical treatment

In addition to the medication, you will undergo conventional non-surgical treatment, which includes scaling and root surfacing. This is a standard procedure to clean the teeth and remove plaque and tartar.

This treatment aims to improve your periodontal health and will be performed by a dental professional.

5 follow-up visits

You will attend follow-up visits to monitor your progress. These visits will include re-evaluation of your periodontal health, similar to the baseline assessment.

The primary endpoint, which is the depth of periodontal pockets, will be measured 28 days after the end of the antiviral treatment and 2 months after root surfacing.

6 periodontal re-evaluation

During the periodontal re-evaluation visit, the effectiveness of the treatment will be assessed. This includes measuring the depth of periodontal pockets and other clinical indices.

If necessary, surgical options may be considered for patients with persistent periodontal pockets and good oral hygiene.

7 quality of life assessment

Your oral health’s impact on your quality of life will be evaluated using a questionnaire. This helps to understand how your oral condition affects your overall well-being.

The questionnaire is designed to capture various aspects of your daily life and how they are influenced by your oral health.

8 end of trial

At the end of the trial, a final assessment will be conducted to evaluate the overall outcomes of the treatment.

The results will contribute to understanding the effectiveness of the antiviral medication in treating generalized periodontitis.

Who Can Join the Study?

  • Age must be 18 years or older.
  • Must have a diagnosis of generalized periodontitis, which is a type of gum disease, at stage III or IV and grade A, B, or C.
  • If you are of childbearing age, you need to use an effective method of contraception while participating in the study.
  • You must sign an informed consent form, which means you agree to participate after understanding the study details.
  • You need to be a member of a social security scheme.

Who Cannot Join the Study?

  • Patients with severe gum disease (stage III or IV) cannot participate.
  • Patients with advanced gum disease (grade A, B, or C) are not eligible.
  • Individuals who are not within the specified age range for the study cannot join.
  • Participants who are part of a vulnerable population are excluded.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Ajcnetdchm Plynshlq Hivtwush Dd Mazgudary Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.07.2023

Trial locations

Investigated drugs:

Valaciclovir is an antiviral medication used in this clinical trial to help treat generalized periodontitis, which is a serious gum infection. The role of valaciclovir in the trial is to see if it can improve the treatment outcomes when used alongside standard dental cleaning procedures. It works by reducing the activity of viruses in the body, which may help in managing the infection and inflammation associated with periodontitis.

Scaling and Root Planing is a conventional non-surgical treatment used in this trial for managing generalized periodontitis. This therapy involves deep cleaning of the teeth and gums to remove plaque and tartar buildup. The goal is to smooth out the roots of the teeth, which helps the gums reattach to the teeth and reduces the depth of gum pockets, ultimately improving gum health.

Investigated diseases:

Generalized periodontitis (stage III or IV and grade A, B or C) – Generalized periodontitis is a chronic inflammatory disease affecting the tissues surrounding the teeth, leading to the progressive destruction of the periodontal ligament and alveolar bone. In stages III and IV, the disease is characterized by severe attachment loss and bone destruction, which can result in tooth mobility and potential tooth loss. The disease progresses through the accumulation of bacterial plaque and calculus, which triggers an inflammatory response. As the condition advances, patients may experience symptoms such as gum bleeding, recession, and deep periodontal pockets. The disease can be classified into grades A, B, or C, based on the rate of progression, with grade C indicating a rapid progression.

Trial ID:
2022-501957-35-00
Protocol code:
20-API-02
Trial Phase:
Therapeutic confirmatory (Phase III)

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