Locally Delivered Antibiotics for the Treatment of Periodontitis

NCT ID: NCT04125706

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2020-09-01

Brief Summary

The sample consists of patients with moderate to severe periodontitis who will be subjected to machanical therapy in combination to local antibiotics. The participants will be divided into two groups, mechanical therapy with metronidazole hyclate, and mechanical therapy with minocycline hydrochloride. Both antibiotics will be delivered locally as gels. Outcome measures include probing pocket depth and several gingival indices. IL6 will be also measured for all participants.

Detailed Description

Forty-four patients in the age group of 25-50 years (males and females) who are suffering from periodontitis with almost similar probing depth bilaterally (≥ 6 mm) at the selected sites and exhibiting bleeding on probing.

A written informed consent will be taken from the patients prior to the study.

Each patient will be recalled 4 weeks after completion of both sides supra-gingival scaling, which formed the baseline visit. Plaque scores will be brought to zero, and the probing pocket depth and gingival index, will be recorded on the proforma specially prepared for the purpose.

The selected treatment sites will be then divided into two groups, and sub-gingival SRP will be performed prior to the delivery of the drugs at the test sites.

• Group I: Consist of periodontal pockets on the left side of maxillary or mandibular arch and received sub-gingival Minocycline 2% gel.
• Group II: Consist of periodontal pockets on the left side of maxillary or mandibular arch and received Metronidazole 0.75% gel.

The right side will be left as a control in both groups Patients will be recalled after 6 weeks from the baseline visit to record the plaque index, gingival index, bleeding index and probing depth (UNC probe 12 mm).

Statistical Analysis:

The unit of measurement in this study is the site, rather than the subject. Student-t test was To compare between Group 1 (Minocycline 2 %) and Group 2 (Metronidazole 0.75 %), Data will check for normality, if the data normally distributed Independent t-test will use to test if there any significant differences between groups, otherwise if not normally Mann -Whitney U-test (Non-parametric) will use to detects the difference.

To achieve 80% power of statistical test to detect the differences between Metronidazole and Minocycline With 5 % level of significant, 19.6 reduction in probing depth (previous study-vi) and standard deviation of 0.23, using the following formula.

n=(2σ^2 〖(Z_(β+Z_(1-α/2) ))〗^2)/d^2 22 per group (minimum sample size) where: σ =0.23 Zβ =0.84 Z(1-α/2) =1.96, d= 19.6%

For objective 2, the statistical test in case of normal data distribution will be paired t test or will use Willcoxon Sign Ranked test if it not normally distributed.

To achieve 80% power of statistical test to detect the differences between Metronidazole and Minocycline. With 5% level of significant.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Mincycline hydrochloride 2% oral gel

Minocycline will be delivered locally in the periodontal pocket.

Group Type: EXPERIMENTAL

Minocycline Topical

Intervention Type: DRUG

Minocycline will be delivered locally in the periodontal pocket

Metronidazole hylcate 0.75 % oral gel

Metronidazole gel will be delivered locally in the periodontal pocket.

Group Type: EXPERIMENTAL

Metronidazole Topical Gel

Intervention Type: DRUG

Metronidazole will be delivered locally in the periodontal pocket

Interventions

Minocycline Topical

Minocycline will be delivered locally in the periodontal pocket

Intervention Type: DRUG

Metronidazole Topical Gel

Metronidazole will be delivered locally in the periodontal pocket

Intervention Type: DRUG

Other Intervention Names

Dentomycin oral gel will be delivered locally in the periodontal pocket; Roza 0.75% will be delivered locally in the periodontal pocket

Eligibility Criteria

Inclusion Criteria

• Patients suffering from chronic periodontitis with almost similar probing depth bilaterally (≥
• 6 mm) at the selected sites and exhibiting bleeding on probing Patients with no caries and restorations on the selected teeth
• Patients showing effective individual oral hygiene.

Exclusion Criteria

Patients presenting with history of intake of local and/or systemic antibiotic therapy for the last 3 months

• Patients with known systemic and debilitating diseases (Muscular Dystrophy)
• Patients presenting with known adverse reactions to any component of the test agent
• Patients on anticoagulant therapy
• Pregnant and lactating females
• Smokers
• Patients in a regular use of mouth wash

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Riyadh Elm University

OTHER

Sponsor Role: lead

Responsible Party

Sasha Suliman

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sasha M Suliman, MSc

Role: PRINCIPAL_INVESTIGATOR

Ar Riyad, Saudi Arabia, 11681

Central Contacts

Sasha M Suliman, MSc

Role: CONTACT

sashasuliman@riyadh.edu.sa

966533215808

Omer AlKadhi

Role: CONTACT

Omar.AlKadhi@riyadh.edu.sa

Other Identifiers

FRP/2019/53

Identifier Type: -

Identifier Source: org_study_id