UMIN-CTR Clinical Trial

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