Peri-Implant Mucositis Treatment with a Chlorexidine Gel with A.D.S. 0.5%, PVP-VA and Sodium DNA vs a Placebo Gel: A Randomized Controlled Pilot Clinical Trial

Felice Lorusso¹, Gianluca Tartaglia², Francesco Inchingolo³, Antonio Scarano^1,4,*

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¹ Department of Innovative Technologies in Medicine and Dentistry, University of Chieti-Pescara, 66100 Chieti, Italy

² Department of Biomedical, Surgical and Dental Sciences, School of Dentistry, University of Milan, 20122 Milan, Italy

³ Department of Interdisciplinary Medicine, University of Medicine Aldo Moro, 70124 Bari, Italy

⁴ Department of Oral Implantology, Dental Research Division, College Ingà, UNINGÁ, 29312 Cachoeiro de Itapemirim, Espirito Santo, Brazil

^*Correspondence: ascarano@unich.it (Antonio Scarano)
Academic Editor: Luca Testarelli

Front. Biosci. (Elite Ed) 2022, 14(4), 30; https://doi.org/10.31083/j.fbe1404030

Submitted: 1 June 2022 | Revised: 30 June 2022 | Accepted: 6 July 2022 | Published: 31 October 2022

This is an open access article under the CC BY 4.0 license.

Abstract

Background: Peri-implant mucositis is a bacterial and inflammatory disease of implant surrounding soft tissues. Chlorhexidine (CHX) associated with PVP-VA (Polyvinylpyrrolidone/vinyl acetate) has an adjuvant function in the antibacterial activity: it protects the film-forming layer, due to polymer, from microbial contamination or over-infection, and prolongs its permanence, without a direct action on the tissues and wounds. Sodium DNA is able to improve gingival trophism. The aim of the study was to compare a gel with CHX and antidiscoloration system (A.D.S.) 0.5% with the addition of PVP-VA and sodium DNA with a placebo gel without chlorexidine in peri-implant mucositis treatment. Methods: Trial design: A single center randomized controlled pilot clinical trial was conducted on a total of 24 patients with mucositis, randomly allocated into two groups. In the group (A) (n = 12) patients were treated with a gel with CHX + A.D.S. 0.5% while a placebo gel was used in the group (B) (n = 12). Outcome: Plaque Index (PI) (primary outcome), Bleeding on probing (BOP) and Gingival Index (GI) (secondary outcomes) were assessed at baseline and at 2 weeks after treatment period. Results: Mean PI score recorded at baseline was 2.4 $\pm$ 0.4 [95% CI: –2.682/7.482] in the group (A) and 2.2 $\pm$ 0.5 [95% CI: –4.153/8.553] in the group (B) (p $>$ 0.05) while mean PI score at 2 weeks was 0.5 $\pm$ 0.4 [95% CI: –4.582/5.582] and 1.7 $\pm$ 1.9 [95% CI: –9.736/13.14] in the group and in the group respectively (p $<$ 0.05). Mean BOP value at baseline was 57.1 $\pm$ 15.2% [95% CI: –136.0/250.2] in the group (A) and 55.3% $\pm$ 11.7% [95% CI: –93.36/204.0] (p $>$ 0.05) while mean BOP value at 2 weeks follow-up was 14.3% $\pm$ 6.6% [95% CI: –69.56/98.16] (A) and 45.4% $\pm$ 9.8% [95% CI: –79.12/169.9] (B) respectively (p $<$ 0.05). Conclusions: A significant reduction in gingival inflammation indexes was found at 2 weeks in patients with peri-implant mucositis treated with a gel with CHX + A.D.S. 0.5% with the addition of PVP-VA and sodium DNA compared to those treated with a placebo gel. Clinical Trial Registration: 2019-004976-20.