Levels of Matrix Metalloproteinase-8 After Intrapocket Treatment in Moderate Periodontitis Patients.
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Using local delivery drugs as adjunctive to scaling and root planing and evaluating gingival
      crevicular fluid (GCF) biological molecular markers (MMP-8).
    

Detailed description: 
      Study sample and setting A sample size of twenty patients per group (number of groups = 2)
      (total sample size = 40 patients) is the sufficient required sample as statistically
      significant with 80% power. The sample size was calculated using g power version 3.1.9.2.
      patients will be recruited from the outpatient clinic of the Department of Oral Medicine,
      Periodontology, Diagnosis and Oral Radiology. Faculty of Dentistry, Alexandria University.

      Treatment will be in accordance with the principles of the modified Helsinki code for human
      clinical studies (2013).

      The clinical study will be conducted following the ethical guidelines for conduct of research
      on human subjects, by the Faculty of Dentistry, Alexandria University (IRB NO:00010556 - IORG
      0008839).

      Data management and statistical analysis The data will be processed and analysed using
      statistical package for social sciences program SPSS (20.0) software*. The study will include
      descriptive and analytical data. A P-value of less than 0.05 will be considered statistically
      significant.
    

Intervention name(s): lemongrass essential oil gel; Placebo; Scaling and root planing
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): The lemongrass oil gel will be administered by means of a syringe with a bent, blunt-end needle. The needle will be carefully inserted into the periodontal pocket and the gel will be applied in the test sites in a gentle probing manner, attempting to fill the full extent of the pocket. The gel will be applied up to the gingival margin and the excess gel will be removed with sterile gauze.
Periodontal dressing will be applied after the delivery of the drug, and they will be also asked not to eat for thirty minutes.
After placement of the gel in situ, patients will be instructed to follow strict oral hygiene protocol and not chew hard or sticky foods at the gel placement sites for rest of the week.; The placebo will be administered by means of a syringe with a bent, blunt-end needle. The needle will be carefully inserted into the periodontal pocket and the gel will be applied in the test sites in a gentle probing manner, attempting to fill the full extent of the pocket. The gel will be applied up to the gingival margin and the excess gel will be removed with sterile gauze.
Periodontal dressing will be applied after the delivery of the drug, and they will be also asked not to eat for thirty minutes.
After placement of the gel in situ, patients will be instructed to follow strict oral hygiene protocol and not chew hard or sticky foods at the gel placement sites for rest of the week.; Conventional mechanical treatment by ultra-sonic scalers
Other intervention name(s): Cymbopogon citratus oil gel; Carbopol®-Based pH-Sensitive gel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: -Cymbopogon citratus oil gel /-Placebo gel. will be intrapocket application as an adjunctive treatment to conventional therapy
Masking: Single (Participant)
Primary purpose: Treatment