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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047711
Receipt No. 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

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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
Email 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
Email morose2012@sina.cn

Sponsor
Institute Department of Periodontics,Beijing Stomatological Hospital, Capital Medical University
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054391

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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