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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Hungary
Semmelweis University
RECRUITING
Budapest
Italy
University of Naples Federico II
RECRUITING
Naples
Contact Information
Primary
Luca Ramaglia
luca.ramaglia@unina.it
+393476912911
Backup
Péter Windisch
parodontologia@dent.semmelweis-univ.hu
318-5222
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2025-07-01
Participants
Target number of participants: 92
Treatments
Experimental: NaOCl + HA 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, the HA-based gel will be applied in the peri-implant sulcus by means of a blunt-tipped needle.
Active_comparator: NSMD Group
Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler tips.
Related Therapeutic Areas
Sponsors
Leads: Federico II University
Collaborators: Semmelweis University

This content was sourced from clinicaltrials.gov