PeriodontitisNCT04125706
Locally Delivered Antibiotics for the Treatment of Periodontitis
A study testing Minocycline Topical and Metronidazole Topical Gel in people with Periodontitis, run by Riyadh Elm University.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Minocycline Topical and Metronidazole Topical Gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Omer AlKadhi contact
About this study
Official title: Locally Delivered Antibiotics for the Treatment of Periodontitis Topical Doxycycline Versus Minocycline Gels as an Adjunct to Mechanical Treatment
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.
Read the 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
- Being tested
- Minocycline Topical, Metronidazole Topical Gel
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline TopicalDrug
Also called Dentomycin oral gel will be delivered locally in the periodontal pocket
Minocycline will be delivered locally in the periodontal pocket
Metronidazole Topical GelDrug
Also called Roza 0.75% will be delivered locally in the periodontal pocket
Metronidazole will be delivered locally in the periodontal pocket
| Study group | Role | What they receive |
|---|---|---|
| Mincycline hydrochloride 2% oral gel | Experimental | Minocycline will be delivered locally in the periodontal pocket. Receives: Drug: Minocycline Topical |
| Metronidazole hylcate 0.75 % oral gel | Experimental | Metronidazole gel will be delivered locally in the periodontal pocket. Receives: Drug: Metronidazole Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
plaque index
To measure the state of oral hygiene as:
0 = No plaque in the gingival area
- = A film of plaque adhering to the free gingival margin and adjacent of the tooth
- = Moderate accumulation of soft deposits within the gingival pocket
- = 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.
Measured: Baseline to six weeks
gingival index
To assess the gingival condition and record qualitative chances in the gingiva as:
0 = Normal gingiva
- = Mild inflammation - slight change in color and slight edema but no bleeding on probing.
- = Moderate inflammation - redness, edema and glazing, bleeding on probing
- = 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.
Measured: 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.
Measured: 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
Measured: Baseline to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups will receive two different locally delivered antibiotics
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Elm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sasha Suliman, Riyadh Elm University
- Investigators
- Sasha M Suliman, MSc, Principal investigator, Ar Riyad, Saudi Arabia, 11681
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125706
- Sponsor's protocol ID
- FRP/2019/53
- Status last verified
- Oct 2019
- First submitted
- 11 Oct 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locally Delivered Antibiotics for the Treatment of Periodontitis Topical Doxycycline Versus Minocycline Gels as an Adjunct to Mechanical Treatment
- ClinicalTrials.gov ID
- NCT04125706
- Acronym / sponsor ID
- FRP/2019/53
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riyadh Elm UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups will receive two different locally delivered antibiotics
| Arm | Type | Receives |
|---|---|---|
| Mincycline hydrochloride 2% oral gel | Experimental | Drug: Minocycline TopicalMinocycline will be delivered locally in the periodontal pocket. |
| Metronidazole hylcate 0.75 % oral gel | Experimental | Drug: Metronidazole Topical GelMetronidazole gel will be delivered locally in the periodontal pocket. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minocycline TopicalAlso: Dentomycin oral gel will be delivered locally in the periodontal pocketMinocycline will be delivered locally in the periodontal pocket | Drug | Mincycline hydrochloride 2% oral gel |
| Metronidazole Topical GelAlso: Roza 0.75% will be delivered locally in the periodontal pocketMetronidazole will be delivered locally in the periodontal pocket | Drug | Metronidazole hylcate 0.75 % oral gel |
Primary outcome
plaque index
Time frame: Baseline to six weeks
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.
gingival index
Time frame: Baseline to six weeks
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.
probing depth
Time frame: Baseline to six weeks
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.
IL6
Time frame: Baseline to six weeks
In healthy subjects it ranges from 0.5-5 pg/ml In eosinophilic subjects it ranges from 3-18pg/ml in plasma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer AlKadhi contact
Sasha M Suliman, MSc principal investigator
Ar Riyad, Saudi Arabia, 11681
Questions about this trial
What is this clinical trial studying?
A study testing Minocycline Topical and Metronidazole Topical Gel in people with Periodontitis, run by Riyadh Elm University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sasha M Suliman, MSc (966533215808, sashasuliman@riyadh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plaque index (time frame: Baseline to six weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.