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

Parodontitis Clinical Trial

— SFYCT  

Official title:

Evaluation of the Efficacy and Safety of STERIFY GEL in the Treatment of Periodontitis Following Scaling and Root Planing: Pivotal, Prospective, Single-center, Split-mouth, Randomized, Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05975177
• Other study ID #: SFYCT
• Status: Completed
• Phase: N/A
• Start date: December 3, 2022
• Est. completion date: April 6, 2023

Study information

• Verified date: August 2023
• Source: Sterify S.r.l.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of the study is to test the safety and efficacy of STERIFY GEL in promoting healing of periodontal pockets following SRP, compared with treatment with SRP alone. With specific visco-elastic and mucoadhesive properties, STERIFY GEL easily penetrates into the deepest and hard-to-reach areas of periodontal and peri-implant pockets, adhering to the gingival tissue and alveolar bone, providing complete coverage of the pockets. The effect of STERIFY GEL is promoted by a physical mechanism of action. After SRP, the gel is applied into the gingival pocket, where it acts primarily as a filler to restore volume, physically preventing bacteria from entering and reinfecting the pocket. STERIFY GEL can thus mechanically protect treated pockets and bone defects, promoting tissue healing. The occluding action at the level of periodontal and peri-implant gingival pockets, in synergy with the accessory action of hydroxytyrosol, nisin, and magnesium ascorbyl phosphate, prevents bacterial recolonization and promotes subsequent tissue regeneration.

Although SRP surgery is considered a gold standard treatment for periodontitis, it may in some cases be insufficient to decontaminate the pocket allowing bacteria to recolonize the tissues promoting new inflammation that can worsen the clinical picture.STERIFY GEL may find useful application in cases of moderate to severe chronic periodontal disease as an adjunctive treatment following SRP to improve and accelerate healing parameters and prevent recurrent inflammation and infection.In addition, antimicrobial control action prevents antibiotic use and the risk associated with antibiotic resistance.Such control of periodontal disease also allows for the maintenance of patients who cannot undergo surgical treatment (e.g., patients on bisphosphonate therapy, defected etc.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 6, 2023
• Est. primary completion date: March 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Parodontitis
• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
Italy	Odontostomatologia, ASST dei Sette Laghi	Varese

Sponsors (2)

Lead Sponsor	Collaborator
Sterify S.r.l.	Sciently di Omar Sabry

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gingival recession	Measurement by periodontal probe of the distance from the cemento-enamel junction to the depth of the free gingival margin.	Pre-treatment, 1 month, 2 months, 3 months
Secondary	Clinical Attachment Level	Measurement by periodontal probe of the distance in millimeters between the amelo-cement junction (the boundary between the crown and root of the tooth) and the bottom of the pocket.It can also be calculated by summing the gingival recession and the periodontal pocket.	Pre-treatment, 1 month, 2 months, 3 months
Secondary	Plaque Index	The plaque index (PI) (Silness J & Löe H), is recorded, during the clinical periodontal examination, at 4 to 6 sites for each tooth element present by circumferential probing with a manual periodontal probe.The 6 dental sites considered are: buccal, mesio-buccal, disto-buccal, lingual, mesio-lingual, and disto-lingual (if there are 4: distal, proximal, palatine/lingual, buccal).Each site is given a score from 0 to 3, where: 0 no plaque, 3 abundance of plaque.	Pre-treatment, 1 month, 2 months, 3 months
Secondary	Bleeding Index	% measurement. Each site is gently probed with a periodontal probe at six sites (mesial, middle, and distal on both buccal and lingual surfaces): bleeding is assessed as present or absent, and the number of sites where bleeding is present is recorded.The number of sites where bleeding is recorded is divided by the total number of sites available in the mouth and multiplied by 100 to express the bleeding index as a percentage.	Pre-treatment, 1 month, 2 months, 3 months
Secondary	Furcations	0: no furcation1: horizontal loss of supporting tissues not exceeding one third of the tooth width 2: horizontal loss of supporting tissues exceeding one-third of the tooth width but not affecting the entire furcation 3: Horizontal loss of supporting tissues "passing through" the entire furcation area.	Pre-treatment, 1 month, 2 months, 3 months
Secondary	Grade of Mobility	The survey of dental mobility completes the objective examination. It is important to remember that mobility can be periodontal, traumatic, or endodontic in origin and should be assessed by the application of slight forces conveyed through two instruments and not with the fingers.; Class 0: physiological mobility.Class 1: slightly increased mobility, slight horizontal displacements (Perceptible mobility <1mm in buccolingual direction) Class 2: markedly increased mobility without functional impediment, displacements in horizontal direction (>1mm but <2mm) Class 3: markedly increased mobility with functional impediment, displacements even in vertical direction (>2mm or depressibility in the socket)	Pre-treatment, 1 month, 2 months, 3 months
Secondary	Quantification of bacterial contamination	Bacterial contamination assessed through quantitative PCR.	Pre-treatment, 3 months