CompletedNot Applicable

Treatment of Peri-implant Mucositis by Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel

Hungary, Italy92 participantsStarted 2023-06-06

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change of BoP (+/-)

Timeframe: baseline, 6 months after periodontal therapy

Trial details

NCT IDNCT05926297

SponsorFederico II University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-01

View on ClinicalTrials.gov More Peri-implant Mucositis trials