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Evaluation of the Efficacy of STERIFY GEL in the Treatment of Periodontitis Following Scaling and Root Planing

NCT05975177 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-08-07

No results posted yet for this study

Summary

The purpose of this clinical study is to evaluate the safety and efficacy of treating periodontal disease with the STERIFY GEL medical device in combination with SRP procedure, in terms of periodontal pocket healing. Efficacy will be compared with the use of the nonsurgical SRP technique alone, which is considered a gold standard treatment for periodontitis, with the aim of observing improved results when using the STERIFY GEL device.

The study is prospective, split-mouth.STERIFY GEL will be administered into the periodontal pockets of one or two segments of patients undergoing whole-mouth extended SRP, with the contralateral segments serving as controls (split-mouth), in a single session.

Conditions

  • Parodontitis

Interventions

DEVICE

Sterify Gel

A mucoadhesive polymeric hydrogel in a prefilled syringe for nonsurgical treatment of periodontal and peri-implant pockets, composed of polyvinyl polymers, hydroxytyrosol, nisin, and magnesium ascorbyl phosphate

PROCEDURE

Scaling and root planing

The non-surgical procedure involved SRP under local anesthesia with EMS scalers and Gracey curettes.

Sponsors & Collaborators

  • Sciently di Omar Sabry

    collaborator UNKNOWN

  • Sterify S.r.l.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-03
Primary Completion
2023-03-11
Completion
2023-04-06

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05975177 on ClinicalTrials.gov