UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043302 |
|---|---|
| Receipt number | R000049426 |
| Scientific Title | Efficacy of catechin gel as a local drug delivery for patients with periodontitis |
| Date of disclosure of the study information | 2021/02/10 |
| Last modified on | 2021/02/10 21:08:03 |
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Basic information
Public title
Study on the effect of catechin gel on oral tissues (mainly periodontal tissues)
Acronym
Effect of catechin gel on periodontal tissue
Scientific Title
Efficacy of catechin gel as a local drug delivery for patients with periodontitis
Scientific Title:Acronym
Efficacy of catechin gel for periodontitis
Region
| Japan |
Condition
Condition
periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyze changes in clinical parameters of periodontitis and periodontopathic bacteria due to topical administration of catechin and minocycline gel into the periodontal pocket.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
With baseline at the end of initial periodontal therapy, placebo gel, catechin gel or minocycline gel was topically administered into the periodontal pocket at a depth of 5 mm or more at baseline, 1 month after final administration. Compare the probing depth with the baseline.
Key secondary outcomes
Bacterial test in periodontal pocket
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
Placebo gels were topically administered (0.5 ml) once a month for three times into the periodontal pockets of patients with periodontitis.
Interventions/Control_2
Catechin gels (2.75 mg/ml) were topically administered (0.5 ml) once a month for three times into the periodontal pockets of patients with periodontitis.
Interventions/Control_3
Minocycline gels (2%) were topically administered (0.5 ml) once a month for three times into the periodontal pockets of patients with periodontitis.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Systemically healthy, 2) Non-smoker, 3) No history of antibiotic therapy and use of antiseptics in the last six months, 4) Having one or more interproximal sites, 5) Patients who had at least two teeth having PPD 5 mm with attachment loss, 6) Radiographic evidence of alveolar bone loss.
Key exclusion criteria
Known or suspected allergies to the food or drugs.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Yorimasa |
| Middle name | |
| Last name | Ogata |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Periodontology
Zip code
271-8587
Address
2-870-1, Sakaecho-nishi, Matsudo, Chiba
TEL
047(360)9362
ogata.yorimasa@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | masaki |
| Middle name | |
| Last name | Tamatsu |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Research Office
Zip code
271-8587
Address
2-870-1, Sakaecho-nishi, Matsudo, Chiba
TEL
047(360)9273
Homepage URL
tamatsu.masaki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Nihon University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nihon University School of Dentistry
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University School of Dentistry at Matsudo
Address
2-870-1 Sakaecho-nishi, Matsudo, Chiba
Tel
047(360)9273
tamatsu.masaki@nihon-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本大学松戸歯学部付属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
18
Results
Clinical parameters and results of bacterial test were not significantly different between the three groups at baseline. PPD and the improved scores of PPD were significantly improved in the minocycline gel group after interventions and as compared to the placebo gel group. Moreover, mean number of S. sanguinis was significantly reduced in the catechin gel group after interventions.
Results date posted
| 2021 | Year | 02 | Month | 10 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The manuscript is incomplete.
Date of the first journal publication of results
Baseline Characteristics
Eighteen patients who visited the outpatient section of Department of Periodontology, Nihon University Hospital School of Dentistry at Matsudo, Chiba, Japan from July 2015 to February 2016, were screened, and 18 individuals (10 males and 8 females; aged 25 to 88 years), diagnosed with Stage III, Grade B periodontitis were included in this study.
Participant flow
The participants were divided into three groups according to the type of treatment allocated, and one site (PPD >5 mm) per patient of maxillary teeth was treated with local drug delivery using the three different gels such as placebo gel (carboxymethyl cellulose), catechin gel or minocycline gel (2% minocycline hydrochloride).
Adverse events
No adverse events
Outcome measures
Clinical parameters, including gingival index (GI) and plaque index (PlI)were considered, and PPD, CAL and BOP were measured.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 10 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 10 | Day |
Last modified on
| 2021 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049426
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/02/10 | Catechin (improved score).xlsx |
