Evaluation of Metronidazole Hydrogel 25% in Stage II and III Periodontitis

Periodontitis Clinical Trial

Official title:

Evaluation of Effects of Subgingival Administration of Metronidazole Hydrogel 25% in Stage II and III Periodontitis: Randomized, Split Mouth, Single-blind Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04983849
• Other study ID #: Prot. RCT 001/2021
• Status: Completed
• Phase: Phase 4
• Start date: July 7, 2021
• Est. completion date: July 7, 2021

Study information

• Verified date: December 2023
• Source: University of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized clinical trial will be performed single-blind to evaluate the effectiveness of sublingual metronidazole hydrogel 25 % in periodontitis.

Description:

A randomized clinical trial will be performed single-blind to evaluate the effectiveness of sublingual metronidazole hydrogel 25 % in periodontitis in stage II and III. At least 40 volunteers between the age of 18 and 80, will be enlisted, with the need to perform the SRP. In half of the mouth will be used the metronidazole hydrogel 25%, while in the other half no drugs will be used of delivered. The study will be carried out in accordance with the Helsinki Declaration and the Protocol will be submitted to the Internal Review Board of the University to obtain authorization. Afterwards, the protocol will be recorded on the databa-se clinicaltrials.gov for clinical trials. The protocol respects the SPIRIT parameters for the compilation of protocols on clinical trials and the study will respect the parameters of CONSORT sta-tement on randomized clinical trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 7, 2021
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 10% of sites with survey depth 5 mm
• Comparable pockets in 4 mouth quadrants
• Health at systemic level

Exclusion Criteria:

• Changes in oral mucosa
• Depth at the poll 5 mm
• Presence of removable prostheses or orthodontic equipment
• Allergies to even a single component of a product in testing• Antibiotic-based treatments during the 6 months preceding the start of testing
• History of previous periodontal treatments in the 12 months preceding the start of the study

Related Conditions & MeSH terms

• Periodontitis

Intervention

Drug:
• metronidazole hydrogel
scaling and root planning in adjunct to the use of metronidazole in the periodontal pocket

Procedure:
• scaling and root planning
scaling and root planning

Locations

Country	Name	City	State
Italy	University of L'Aquila, division of periodontology	L'Aquila

Sponsors (1)

Lead Sponsor	Collaborator
University of L'Aquila

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of MMP8	matrix metalloproteinases (ng/ml)	baseline - 1 week
Primary	Concentration of MMP9	matrix metalloproteinases (ng/ml)	baseline - 1 week
Primary	Concentration of IL1	interleukin (pg/ml)	baseline - 1 week
Primary	Concentration of IL6	interleukin (pg/ml)	baseline - 1 week
Primary	Concentration of IL8	interleukin (pg/ml)	baseline - 1 week
Primary	Concentration of IL17	interleukin (pg/ml)	baseline - 1 week
Primary	Concentration of TNF alfa	tumor necrosis factor alfa (pg/ml)	baseline - 1 week
Primary	Concentration of RANK-L	Receptor activator of nuclear factor kappa-? ligand (pg/ml)	baseline - 1 week
Primary	Concentration of OPG	osteoprotegerin (pg/ml)	baseline - 1 week
Secondary	CAL	clinical attack level (mm)	baseline - 1 week
Secondary	PPD	Probing Pocket Depth (mm)	baseline - 1 week
Secondary	GI	gingival index (0-3)	baseline - 1 week
Secondary	FMPS	full mouth plaque score (0-100%)	baseline - 1 week
Secondary	FMBS	full mouth bleeding score (0-100%)	baseline - 1 week