Mucositis Oral, Peri-implant Mucositis
Conditions
Keywords
Hyaluronic Acid, Peri-implant mucositis, Sodium hypochlorite
Brief summary
The aim of the study is to evaluate the potential of the combination of a sodium hypochlorite-based gel and a hyaluronic acid-based gel as an adjuvant to Non-Surgical Mechanical Debridement (NSMD) in the treatment of mucositis, after 6 months of follow-up. After a meticulous selection, patients will be randomly assigned to Test (Sodium Hypochlorite-based gel + NSMD + Hyaluronic Acid-based gel ) or Control (NSMD) group. All clinical parameters will be recorded and the final evaluation will be performed.
Detailed description
The aim of the study is to evaluate the clinical results of the combination of a sodium hypochlorite-based gel (NaOCl gel) and a cross-linked hyaluronic acid-based gel (HA gel) as an adjuvant to Non-Surgical Mechanical Debridement (NSMD) in the treatment of mucositis, after 6 months of follow-up (Clean & Seal concept). Following the selection through inclusion and exclusion criteria, all patients will be randomly assigned to Test NaOCl-based gel + NSMD + HA-based gel) or Control (NSMD) group. Patients will be recruited at Department of Periodontology (Univeristy of Naples Federico II) and at Department of Periodontology (University of Budapest Semmelweis). Subsequently, after recording of the clinical parameters (BoP, FMPS, FMBS, PD), in the Test group a NaOCl-based gel will initially be applied in the peri-implant sulcus for 30 seconds, without the need for flushing. Furthermore, mechanical therapy (NSMD) will be performed by means of an ultrasonic scaler with a plastic tip. Finally, HA-based gel will be applied in the peri-implant sulcus by means of a blunt-tipped needle. Conversely, Control group will be treated only through the NSMD. All clinical parameters (BoP, FMPS, FMBS, PD) will be recorded again after 6 months for the final evaluation. Data analysis will be performed using statistical software.
Interventions
PROCEDUREApplication NaOCl gel + HA gel
First step: application of NaOCl gel Second step: NSMD Third step: application of HA gel
PROCEDURENon-surgical mechanical debridement
Only mechanical debridement with curettes ans scaler tips
Sponsors
Semmelweis University
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Only patients will be unaware of the type of treatment performed, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization
Intervention model description
The study will be designed as a double-arm randomized controlled clinical trial. Mucositis will be treated with NaOCl-based gel + NSMD + HA-based gel in Test group and with NSMD alone in Control group. All clinical parameters will be recorded and the final evaluation will be performed.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 years; * Non-smokers and smokers ( ≤ 10 cigarettes/day); * Presence of at least 1 implant in mucositis, clinically and radiographically detected; * The implant in mucositis (tissue-level or bone-level) must support a fixed prosthetic device (single crown, 3-element bridge), cemented or screwed.
Exclusion criteria
* Cancer patients; * Uncontrolled diabetic patients; * Prolonged antibiotic treatment or anti-inflammatory treatment in the previous 6 months; * Pregnant or breastfeeding patients; * Implants that support mobile prosthetic products; * Implants in peri-implantitis, detected clinically and radiographically.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of BoP (+/-) | baseline, 6 months after periodontal therapy | Bleeding on periodontal probing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Full-mouth Plaque Score (FMPS; %) | baseline, 6 months after periodontal therapy | Percentage of all sites exhibiting plaque |
| Change of Full-mouth Bleeding Score (FMBS; %) | baseline, 6 months after periodontal therapy | Percentage of all sites exhibiting bleeding |
| Change of Probing Depth (PD; millimeters). | baseline, 6 months after periodontal therapy | Distance from the gingival margin to the bottom of the peri-implant pocket |
Countries
Hungary, Italy
Outcome results
None listed