University of L'Aquila, division of periodontology
L’Aquila, 67100, Italy
NCT Number: NCT04983849
A randomized clinical trial will be performed single-blind to evaluate the effectiveness of sublingual metronidazole hydrogel 25 % in periodontitis.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
L’Aquila, 67100, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
scaling and root planning in adjunct to the use of metronidazole in the periodontal pocket
Other names: Non Surgical Periodontal Therapy
scaling and root planning
Time frame: baseline - 1 week
matrix metalloproteinases (ng/ml)
Time frame: baseline - 1 week
matrix metalloproteinases (ng/ml)
Time frame: baseline - 1 week
interleukin (pg/ml)
Time frame: baseline - 1 week
interleukin (pg/ml)
Time frame: baseline - 1 week
interleukin (pg/ml)
Time frame: baseline - 1 week
interleukin (pg/ml)
Time frame: baseline - 1 week
tumor necrosis factor alfa (pg/ml)
Time frame: baseline - 1 week
Receptor activator of nuclear factor kappa-Β ligand (pg/ml)
Time frame: baseline - 1 week
osteoprotegerin (pg/ml)
Time frame: baseline - 1 week
clinical attack level (mm)
Time frame: baseline - 1 week
Probing Pocket Depth (mm)
Time frame: baseline - 1 week
gingival index (0-3)
Time frame: baseline - 1 week
full mouth plaque score (0-100%)
Time frame: baseline - 1 week
full mouth bleeding score (0-100%)
University of L'Aquila
Other
Evaluation of Effects of Subgingival Administration of Metronidazole Hydrogel 25% in Stage II and III Periodontitis: Randomized, Split Mouth, Single-blind Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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