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

NCT05975177 | Completed

• 1 other identifier: SFYCT
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sterify gel; periodontal disease; periodontal pockets; scaling and root planing; oral health; dental care

Outcome Measures

Primary Outcomes (1)

• Pocket Depth

  Measurement by periodontal probe of periodontal pocket depth. Unit of measurement in mm with a sensitivity of 0.5 mm.

  Pre-treatment, 1 month, 2 months, 3 months

Secondary Outcomes (7)

• Gingival recession

  Pre-treatment, 1 month, 2 months, 3 months

• Clinical Attachment Level

  Pre-treatment, 1 month, 2 months, 3 months

• Plaque Index

  Pre-treatment, 1 month, 2 months, 3 months

• Bleeding Index

  Pre-treatment, 1 month, 2 months, 3 months

• Furcations

  Pre-treatment, 1 month, 2 months, 3 months

Study Arms (2)

Sterify Gel + SRP

EXPERIMENTAL

Scaling and root planing in the assigned site, followed by intra-pocket administration of Sterify Gel, applied to the bottom of the pocket until the gel emerges or becomes visible at the gingival margin

Device: Sterify Gel; Procedure: Scaling and root planing

SRP only

ACTIVE COMPARATOR

Scaling and root planing in the assigned site.

Procedure: Scaling and root planing

Interventions

Sterify Gel DEVICE

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

Sterify Gel + SRP

Scaling and root planing PROCEDURE

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

SRP only; Sterify Gel + SRP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with grade III and IV chronic periodontal disease according to the European Federation of Periodontology classification involving at least two sites
• Adherence to the study and signing of informed consent
• Major age- Participants with a minimum of 6 teeth with periodontal pocket depth greater than 5mm- Participants with at least 20 teeth

You may not qualify if:

• Established hypersensitivity to one or more components of the device- Pregnancy or lactation- Heavy smoker (more than 9 cigarettes per day)- Concomitant dental disease, except periodontitis, or planned treatment that may interfere with the study or study procedure, such as dental surgery or tooth implantation- Diabetes mellitus, rheumatoid arthritis, or other chronic diseases that may affect disease or treatment
• Aggressive periodontitis
• History of radiation or chemotherapy
• Autoimmune mucosal diseases
• Mental illnesses
• Parafunctions such as bruxism
• Use of antibiotics in the past 3 months
• Periodontal surgeries in the past 12 months in the areas covered by the study

Sponsors & Collaborators

• Sterify S.r.l.: lead
• Sciently di Omar Sabry: collaborator

Study Sites (1)

Odontostomatologia, ASST dei Sette Laghi

Varese, 21100, Italy

Location

MeSH Terms

Conditions

Dry Socket; Periodontal Diseases; Periodontal Pocket

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a split-mouth study. 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.

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 3, 2023
• Study Start: December 3, 2022
• Primary Completion: March 11, 2023
• Study Completion: April 6, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)