Locally Delivered Antibiotics for the Treatment of Periodontitis

NCT04125706 | Unknown

• 1 other identifier: FRP/2019/53
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (4)

• plaque index

  To measure the state of oral hygiene as: 0 = No plaque in the gingival area 1. = A film of plaque adhering to the free gingival margin and adjacent of the tooth 2. = Moderate accumulation of soft deposits within the gingival pocket 3. = Abundance of soft matter within the gingival pocket The Plaque Index is the four gingival areas of the tooth (buccal, lingual/palatal, mesial, distal) given a score from 0-3 and scores were added and divided by four. The plaque index for the individual was obtained by adding the indices for the teeth and divide by the number of teeth examined.

  Baseline to six weeks

• gingival index

  To assess the gingival condition and record qualitative chances in the gingiva as: 0 = Normal gingiva 1. = Mild inflammation - slight change in color and slight edema but no bleeding on probing. 2. = Moderate inflammation - redness, edema and glazing, bleeding on probing 3. = Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding. The bleeding will be assessed by gently probing along the wall of the soft tissue of the gingival sulcus. To get the gingival index for the tooth, the four areas of the tooth (buccal, lingual/palatal, mesial, distal) are scored by the sum and divided by four. The gingival index for the individual will be obtained by adding the indices of the teeth and divided by the number of teeth examined.

  Baseline to six weeks

• probing depth

  The distance from the gingival margin to base of the sulcus. Will be measured at six sites per tooth (mesio-buccal, buccal, disto-buccal, disto-lingual, lingual and mesio-lingual) at all teeth with UNC-15 probe.

  Baseline to six weeks

• IL6

  In healthy subjects it ranges from 0.5-5 pg/ml In eosinophilic subjects it ranges from 3-18pg/ml in plasma

  Baseline to six weeks

Study Arms (2)

Mincycline hydrochloride 2% oral gel

EXPERIMENTAL

Minocycline will be delivered locally in the periodontal pocket.

Drug: Minocycline Topical

Metronidazole hylcate 0.75 % oral gel

EXPERIMENTAL

Metronidazole gel will be delivered locally in the periodontal pocket.

Drug: Metronidazole Topical Gel

Interventions

Minocycline Topical DRUG

Minocycline will be delivered locally in the periodontal pocket

Also known as: Dentomycin oral gel will be delivered locally in the periodontal pocket

Mincycline hydrochloride 2% oral gel

Metronidazole Topical Gel DRUG

Metronidazole will be delivered locally in the periodontal pocket

Also known as: Roza 0.75% will be delivered locally in the periodontal pocket

Metronidazole hylcate 0.75 % oral gel

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients suffering from chronic periodontitis with almost similar probing depth bilaterally (≥
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Riyadh Elm University: lead

MeSH Terms

Conditions

Periodontitis

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Sasha M Suliman, MSc

  Ar Riyad, Saudi Arabia, 11681

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sasha M Suliman, MSc

CONTACT

966533215808; sashasuliman@riyadh.edu.sa

Omer AlKadhi

CONTACT

Omar.AlKadhi@riyadh.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Two parallel groups will receive two different locally delivered antibiotics

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 14, 2019
• Study Start: November 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 16, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share