A Topical Desiccant Agent in Association With Manual Debridement in the Treatment of Peri-implant Mucositis
Condition: Peri-implant Mucositis
MeSH terms: Mucositis
Study type: Interventional

Summary: 
      In patients presenting peri-implant mucositis, effective sub-mucosal debridement is crucial
      to prevent peri-implantitis. The aim of this pilot study was to assess the 3-month clinical
      and microbiological effects of a locally delivered liquid desiccant agent with molecular
      hygroscopic properties, in association with sub-gingival manual debridement, in sites with
      peri-implant mucositis.

      Twenty-three patients presenting at least one implant with no radiographically detectable
      bone loss, a pocket probing depth ≥ 4 mm and bleeding on probing, were included in a 3-month
      randomized, parallel-groups, single-blind, prospective study. At baseline (T0), patients were
      randomly assigned to receive a desiccant liquid agent with molecular hygroscopic properties
      before debridement (Test-Group), or a Chlorhexidine 1% disinfectant gel after debridement
      (Control-Group). Treatments were performed also after 7 and 14 days. Peri- implant soft
      tissues assessment (PPD, BOP, mBI, VPI, mPLI) and microbial sampling were assessed at
      baseline and at 3-month follow-up (T1).
    

Detailed description: 
      A single-center, single-masked, parallel-groups, randomized clinical and microbiological
      study, was conducted between July and October 2018 at the Dentistry and Maxillo-facial
      Surgery Clinic, Department of Surgery, Dentistry, Paediatrics and Gynaecology (DIPSCOMI),
      University of Verona, Verona, Italy. The experimental protocol (Protocol HX-GL-ITA13,
      approval date 20/11/2013) was approved by the Ethical Committee of the University of Verona.
      The study was conducted in accordance with the Ethical Principles of the 64th World Medical
      Association Declaration of Helsinki and was consistent with good clinical practices. All
      participants signed a written informed consent.

      The subjects were enrolled among individuals examined through a survey on prevalence of peri-
      implant infections (mucositis and peri-implantitis) in single-crown plateau-design
      locking-taper implants with a 3-year follow-up period. Twenty-three patients, aged between 37
      and 71 years, met the study criteria.

      Patients were randomly assigned (using a predefined computer-generated randomization scheme)
      to the Test-Group, which received the administration of a desiccant liquid with molecular
      hygroscopic properties (HYBENX® Oral Tissue decontaminantTM, HBX) before SRP, or to the
      Control-Group, which received the administration of a disinfectant gel after SRP
      (Chlorhexidine Digluconate CorsodylTM Dental Gel 1%, CHX).

      Chlorhexidine Digluconate CorsodylTM Dental Gel 1% is an antiseptic gel with cationic nature,
      effective against a wide range of Gram positive and negative bacteria, favourable to the
      plaque control and oral inflammation prevention. HYBENX® Oral Tissue decontaminantTM is a
      concentrated aqueous solution of sulfonated aromatics and free sulphates. Once placed onto
      susceptible organic material, the product instantly absorbs free and electrostatically bonded
      water, denaturing the molecular structure of the organic matter. Biofilm is expected to be
      especially sensitive to the disruptive action of HBX solution by virtue of its porous
      structure and high water content. On the Test-Group of this study, HBX was administered
      before the Teflon-curettes debridement and left in contact with supra and sub-gingival plaque
      biofilm for up to 60 seconds, then rinsed with water and evacuated.

      At baseline (T0) subjects were randomly assigned to the Test-Group or to the Control-Group,
      in order to be examined for microbial sampling, peri-implant soft tissues assessment and
      radiographic bone levels. The implants were consequently treated with HBX, before a SRP
      professional session, or CHX, after a SRP professional session. The treatment, performed by
      the same operator, was then repeated on days 7 and 14.
    

Intervention name(s): topical agent
Intervention type(s): Device
Intervention description(s): HBX protocol consisted in product application into the periodontal pocket (starting from the base) with a delivery syringe, second saline solution irrigation after 60 seconds to flush-out the product and Teflon-curettes debridement to remove the deposits.
CHX protocol consisted in Teflon-curettes debridement to remove the deposits, associated with a first saline solution irrigation, and product application into the periodontal pocket (starting from the base) with a delivery syringe.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care