Clinical trial NCT05926297: Treatment of Peri-implant Mucositis by Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel
Official title: Treatment of Peri-implant Mucositis by Non-surgical Debridement and Adjunctive Application of a Combination of Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peri-implant Mucositis
Mucositis Oral
Keywords: Hyaluronic Acid
Peri-implant mucositis
Sodium hypochlorite
Lead sponsor: Federico II University
Sponsor class: OTHER
Collaborators: name: Semmelweis University
First posted: 2023-07-03
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of BoP (+/-)
timeFrame: baseline, 6 months after periodontal therapy
Secondary outcomes:
measure: Change of Full-mouth Plaque Score (FMPS; %)
timeFrame: baseline, 6 months after periodontal therapy
measure: Change of Full-mouth Bleeding Score (FMBS; %)
timeFrame: baseline, 6 months after periodontal therapy
measure: Change of Probing Depth (PD; millimeters).
timeFrame: baseline, 6 months after periodontal therapy
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University
state: HU
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
affiliation: Federico II University
name: Luca Ramaglia
role: PRINCIPAL_INVESTIGATOR
References: