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Clinical and microbiological effects of a single application of sodium hypochlorite gel during subgingival re-instrumentation: a triple-blind randomized placebo-controlled clinical trial

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Abstract

Objectives

The aim of this study is to assess the clinical and microbiological effects of a single subgingival administration of sodium hypochlorite gel (NaOCl) and compare it with 1% chlorhexidine (CHX) gel and a placebo gel following mechanical re-instrumentation during supportive periodontal therapy (SPT).

Materials and methods

Sixty-two patients who had been treated for stage III–IV periodontitis and enrolled in SPT were included in the study based on following criteria: (1) active periodontal therapy completed at least 6 months before enrollment in the study, (2) presence of at least 4 non-adjacent sites with probing pocket depths (PPDs) ≥ 4 mm with bleeding on probing (BOP), or presence of 5–8 mm PPDs with or without BOP. All sites presenting PPD ≥ 4 mm and BOP at baseline and 3-, 6-, and 9-month follow-up timepoints were subgingivally re-instrumented with ultrasounds. Selected patients were randomly assigned into three groups and treated additionally with a single subgingival administration of NaOCl gel (group A); 1% CHX gel (group B); and placebo gel (group C). Main outcome variable was pocket closure at 12 months. Secondary outcome variables were changes in mean PPD, BOP, and clinical attachment level (CAL) along with changes in the numbers of the following five keystone bacterial pathogens: Aggregatibacter actinomycetemcomitans (A.a.), Porphyromonas gingivalis (P.g.), Prevotella intermedia (P.i.), Tannerella forsythia (T.f.), and Treponema denticola (T.d.).

Results

At 12 months, pocket closure was obtained in 77.5% in the NaOCl treated sites. The reduction in PPD was higher with CHX than with NaOCl, although a statistically significant adjunctive effect for NaOCl (P = 0.028) was only observed in comparison with placebo only. Mean CAL improved in all groups and at all timepoints, compared to the baseline (P < 0.05). However, after 6 months, CAL gain was statistically significantly higher in the NaOCl treated group than following application of CHX (P = 0.0026).

Conclusion

In SPT patients, a single adjunctive use of a NaOCl gel may provide benefits in controlling inflammation and residual pockets.

Trial registration

ISRCTN Registry of Clinical Trials (ISRCTN11387188).

Clinical relevance

A baseline single application of NaOCl gel in conjunction with mechanical debridement may achieve substantial pocket closure in patients enrolled in SPT; treatment time, cost, and applicability considerations should be taken into account when selecting this therapy.

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Funding

No funding was obtained for this study.

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Authors and Affiliations

  1. Department of Periodontology, Faculty of Dental Medicine, Anton Sculean Research Center for Periodontal and Peri-Implant Diseases, Victor Babes University of Medicine and Pharmacy, , Timisoara, Romania

    Viorelia Radulescu, Darian Rusu, Octavia Vela, Giorgios Kardaras & Stefan-Ioan Stratul

  2. Department of Endodontics, Faculty of Dental Medicine, TADERP Research Center, Victor Babes University of Medicine and Pharmacy, Timisoara, Romania

    Marius Ion Boariu

  3. Department of Periodontology, Faculty of Dental Medicine, Applicative Periodontal Regeneration Research Unit, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj Napoca, Romania

    Alexandra Roman

  4. Department of Periodontology, Faculty of Dental Medicine, University of Medicine and Pharmacy, Craiova, Romania

    Petra Surlin

  5. Department of Informatics and Medical Biostatistics, Victor Babes University of Medicine and Pharmacy, Timisoara, Romania

    Adrian Voicu

  6. Department of Embryology, Faculty of Dental Medicine, Carol Davila University of Medicine and Pharmacy, Bucuresti, Romania

    Andreea Cristiana Didilescu

  7. Department of Cariology, Endodontology and Periodontology, Centre for Periodontology, University Hospital of Leipzig, Leipzig, Germany

    Holger Jentsch

  8. Department of Periodontology, School of Dental Medicine, University of Naples Federico II, Naples, Italy

    Vincenzo Iorio Siciliano & Luca Ramaglia

  9. Department of Periodontology, University of Bern, Bern, Switzerland

    Anton Sculean

Authors
  1. Viorelia Radulescu
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  2. Marius Ion Boariu
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  3. Darian Rusu
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  4. Alexandra Roman
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  5. Petra Surlin
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  6. Adrian Voicu
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  7. Andreea Cristiana Didilescu
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  8. Holger Jentsch
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  9. Vincenzo Iorio Siciliano
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  10. Luca Ramaglia
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  11. Octavia Vela
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  12. Giorgios Kardaras
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  13. Anton Sculean
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  14. Stefan-Ioan Stratul
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Contributions

Conceptualization: Viorelia Radulescu, Stefan-Ioan Stratul; methodology: Darian Rusu, Giorgios Kardaras; formal analysis and investigation: Viorelia Radulescu; writing—original draft preparation: Marius Ion Boariu, Vincenzo Iorio Siciliano, Octavia Vela; writing—review and editing: Alexandra Roman, Petra Surlin, Andreea Cristiana Didilescu; supervision: Stefan-Ioan Stratul, Anton Sculean, Holger Jentsch, Luca Ramaglia.Viorelia Radulescu and Darian Rusu have equally contributed and can be both considered as first authors. All authors commented on previous versions of the manuscript, read, and approved the final manuscript.

Corresponding author

Correspondence to Marius Ion Boariu.

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Ethics approval

The study was approved by the Research Ethics Committee of the Victor Babes University of Medicine and Pharmacy Timisoara (approval no.1/21.01.2018).

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All study participants provided written informed consent.

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Radulescu, V., Boariu, M.I., Rusu, D. et al. Clinical and microbiological effects of a single application of sodium hypochlorite gel during subgingival re-instrumentation: a triple-blind randomized placebo-controlled clinical trial. Clin Oral Invest 26, 6639–6652 (2022). https://doi.org/10.1007/s00784-022-04618-3

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