UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047711 |
|---|---|
| Receipt number | R000054391 |
| Scientific Title | Effects of Antimicrobial Peptides Application after Non-surgical Periodontal Therapy on Treatment of Stage III and Grade B Periodontitis: A Randomized Clinical and Microbiological Trial |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2022/05/10 21:30:06 |
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Basic information
Public title
Effects of Antimicrobial Peptides Application after Non-surgical Periodontal Therapy on Treatment of Stage III and Grade B Periodontitis: A Randomized Clinical and Microbiological Trial
Acronym
AMPs
Scientific Title
Effects of Antimicrobial Peptides Application after Non-surgical Periodontal Therapy on Treatment of Stage III and Grade B Periodontitis: A Randomized Clinical and Microbiological Trial
Scientific Title:Acronym
AMPs
Region
| Asia(except Japan) |
Condition
Condition
In this randomized clinical trial, we aimed to evaluate the effects of AMPs as an addition to SRP on clinical parameters and microbiological biofilms in patients with Stage III and Grade B periodontitis.
Classification by specialty
| Infectious disease | Surgery in general | Oral surgery |
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of the antimicrobial peptides (AMPs) as an adjunct to scaling and root planning (SRP) on clinical and microbiological outcomes in patients with periodontitis in Stage III and Grade B.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
probing depth,clinical attachment level,Bleeding index, and Microbiological results
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SRP with AMPs group (AMP group)/SRP group
Interventions/Control_2
SRP with AMPs group (AMP group)/SRP with minocycline hydrochloride group (Perio group)
Interventions/Control_3
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were: (1) at least 20 years old, (2) previously untreated Stage III and Grade B periodontitis by clinically and radiologically17, (3) a minimum of 20 natural teeth in the mouth, and more than 4 molars.
Key exclusion criteria
The exclusion criteria were: (1) acute oral lesions or necrotizing ulcerative periodontitis, (2) having received antibiotics within 6 months or the need for antibiotic coverage during experiment, (3) being allergic to minocycline, (4) no orthodontic treatment, (5) a history of systemic diseases, (6) pregnancy, (7) smoker
Target sample size
51
Research contact person
Name of lead principal investigator
| 1st name | Shuchang |
| Middle name | |
| Last name | Xiang |
Organization
School of Stomatology, Capital Medical University
Division name
CCMU
Zip code
100050
Address
Tian Tan Xi Li No.4
TEL
86-10-57099450
qhddenver@126.com
Public contact
Name of contact person
| 1st name | Nannan |
| Middle name | |
| Last name | Han |
Organization
Beijing Stomatological Hospital, Capital Medical University
Division name
CCMU
Zip code
100050
Address
Tian Tan Xi Li No.4
TEL
86-10-57099450
Homepage URL
morose2012@sina.cn
Sponsor or person
Institute
Department of Periodontics,Beijing Stomatological Hospital, Capital Medical University
Institute
Department
Personal name
Funding Source
Organization
National Nature Science Foundation of China, the Discipline Construction Fund of Beijing Stomatological Hospital, Beijing Stomatological Hospital, Capital Medical University Young Scientist Program .
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
China
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Beijing Stomatological Hospital, Capital Medical University
Address
Tian Tan Xi Li No.4
Tel
86-10-57099450
morose2012@sina.cn
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
Beijing Stomatological Hospital, Capital Medical University
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://wiley.atyponrex.com/dashboard
Publication of results
Unpublished
Result
URL related to results and publications
https://wiley.atyponrex.com/dashboard
Number of participants that the trial has enrolled
51
Results
Probing depth:the reduction was significantly higher in the AMP group than in the other two groups (p<0.001).
Attachment level and Bleeding index: The AMP group at 90 days not only showed an increase in attachment gain and reduction in the bleeding index compared with the baseline of this group but also showed a significantly higher increase than the other two groups (p< 0.05).
Results date posted
| 2022 | Year | 05 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients with Stage III and Grade B Periodontitis
Participant flow
https://wiley.atyponrex.com/dashboard
Adverse events
no
Outcome measures
https://wiley.atyponrex.com/dashboard
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 07 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 10 | Day |
Last modified on
| 2022 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054391
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