Effects of AMP Application After Non-surgical Periodontal Therapy on Treatment of Periodontitis
Primary Purpose
Periodontitis
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Oral biological antimicrobial gel
minocycline hydrochloride ointment
SRP
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
Inclusion Criteria:
- At least 18 years old
- Previously untreated Stage III and Grade B periodontitis by clinically and radiologically。In 2018, EEP and AAP sorted out periodontitis into four classifications (Stage I to IV) based on several variables including clinical attachment loss, amount and percentage of bone loss, probing depth, presence and extent of angular bony defects and furcation involvement, tooth mobility, and tooth loss due to periodontitis, and three levels (grade A: low risk, grade B: moderate risk, grade C: high risk of progression) according to the rate of disease progression.
- A minimum of 20 natural teeth in the mouth, and more than 4 molars.
Exclusion Criteria:
- Acute oral lesions or necrotizing ulcerative periodontitis,
- Having received antibiotics within 6 months or the need for antibiotic coverage during experiment,
- Being allergic to minocycline,
- No orthodontic treatment,
- A history of systemic diseases,
- Pregnancy,
- Smoker
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
AMP Group
Perio Group
SRP Group
Arm Description
scaling and root planning and subgingival application of antimicrobial peptide gel
scaling and root planning and subgingival application of minocycline hydrochloride ointment
scaling and root planning
Outcomes
Primary Outcome Measures
Periodontal probing depth were assessed using a Williams periodontal probe((Hu-Friedy)
from the gingival margin to the bottom of the periodontal pocket
Attachment level were assessed using a Williams periodontal probe((Hu-Friedy)
from the cementoenamel junction, crown margin or restoration to the bottom of the pocket
Bleeding index were assessed using a Williams periodontal probe((Hu-Friedy) ,the rating method was assessed using the criteria of Mazza(Mazza, Newman, & Sims, 1981).
Bleeding index :
0 = normal appearance of the gingiva and no bleeding on sulcus probing.
= normal appearance of the gingiva but bleeding on probing of the sulcus.
= bleeding on probing and gingival color change without swelling.
= bleeding on probing, gingival color change with mild swelling.
= bleeding on probing with marked gingival swelling, with or without color change.
= bleeding on probing, L Spontaneous bleeding, gingival color change with marked swelling, with or without ulceration.
Periodontal microorganisms within subgingival plaque by Mini Grace scaler (Remove the supragingival plaque with a probe, gently put the sterile Mini Grace scaler into the periodontal pocket)
Subgingival plaque storing: Specimens were collected and placed on ice immediately after sampling, transported to the laboratory within 15min and stored at -80°C. Plaque were conveyed on dry ice to the laboratory at Beijing Allwegene Tech, Ltd (Beijing, China) within 5 h. The microbial genomic DNA was isolated, amplified by PCR, and then the V3-V4 hypervariable regions of the 16S rRNA gene18 were subjected to high-throughput sequencing using the Illumina Miseq PE300 sequencing platform (Illumina, Inc. CA, USA).
Secondary Outcome Measures
Full Information
NCT ID
NCT05530252
First Posted
September 2, 2022
Last Updated
September 14, 2022
Sponsor
Beijing Stomatological Hospital, Capital Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05530252
Brief Title
Effects of AMP Application After Non-surgical Periodontal Therapy on Treatment of Periodontitis
Official Title
Effects of Antimicrobial Peptides Application After Non-surgical Periodontal Therapy on Treatment of Stage III and Grade B Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 5, 2022 (Anticipated)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Stomatological Hospital, Capital Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic periodontitis is an infectious disease of periodontal support tissues caused by bacterial biofilm, which leads to inflammation and destruction of periodontal support tissues ultimately resulting in tooth loss.In the clinic, patients with Stage III and Grade B periodontitis are difficult to gain desired outcomes on account of deep periodontal pockets, complicated anatomy, the removal of subgingival dental biofilms, and control of residual inflammation. A large number of studies have indicated that the effectiveness of local application of antibiotics as an adjunct to scaling and root planning (SRP), such as the antimicrobial and minocycline hydrochloride could affect bacterial metabolism and inhibit biofilm attachment particularly in terms of pocket depth reduction and attachment level gain. However, the use of wide-spectrum antibiotics may cause some inevitable side effects including drug resistance, pathogens and probiotics were eliminated leading to diversity of microbiota diminished, and toothstaining. To solve the problems of antibiotics in the clinic, antimicrobial peptides (AMPs) may be considered as an alternative to conventional antibiotics drugs.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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The patients did not know their group or the drugs they were given
Allocation
Randomized
Enrollment
51 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AMP Group
Arm Type
Experimental
Arm Description
scaling and root planning and subgingival application of antimicrobial peptide gel
Arm Title
Perio Group
Arm Type
Active Comparator
Arm Description
scaling and root planning and subgingival application of minocycline hydrochloride ointment
Arm Title
SRP Group
Arm Type
Other
Arm Description
scaling and root planning
Intervention Type
Drug
Intervention Name(s)
Oral biological antimicrobial gel
Other Intervention Name(s)
Biokiller Oral Biological Antimicrobial Gel
Intervention Description
The patients were divided into subgingival scaling, and Oral Biological Antimicrobial Gel was used in the periodontal pocket after scaling. The injection probe with gel was inserted into the periodontal pocket, and the injection was slowly pushed, and the injection was gradually withdrawn during the injection, until a little gel was found at the mouth of the bag.
Intervention Type
Drug
Intervention Name(s)
minocycline hydrochloride ointment
Other Intervention Name(s)
Periocline
Intervention Description
The patients were divided into subgingival scaling, and minocycline hydrochloride ointment was used in the periodontal pocket after scaling. The injection probe with gel was inserted into the periodontal pocket, and the injection was slowly pushed, and the injection was gradually withdrawn during the injection, until a little gel was found at the mouth of the bag.
Intervention Type
Other
Intervention Name(s)
SRP
Intervention Description
only scaling and root planning was performed on the patient
Primary Outcome Measure Information:
Title
Periodontal probing depth were assessed using a Williams periodontal probe((Hu-Friedy)
Description
from the gingival margin to the bottom of the periodontal pocket
Time Frame
Change from Baseline Periodontal probing depth at 90 days
Title
Attachment level were assessed using a Williams periodontal probe((Hu-Friedy)
Description
from the cementoenamel junction, crown margin or restoration to the bottom of the pocket
Time Frame
Change from Baseline Attachment level at 90 days
Title
Bleeding index were assessed using a Williams periodontal probe((Hu-Friedy) ,the rating method was assessed using the criteria of Mazza(Mazza, Newman, & Sims, 1981).
Description
Bleeding index :
0 = normal appearance of the gingiva and no bleeding on sulcus probing.
= normal appearance of the gingiva but bleeding on probing of the sulcus.
= bleeding on probing and gingival color change without swelling.
= bleeding on probing, gingival color change with mild swelling.
= bleeding on probing with marked gingival swelling, with or without color change.
= bleeding on probing, L Spontaneous bleeding, gingival color change with marked swelling, with or without ulceration.
Time Frame
Change from Bleeding index at 90 days
Title
Periodontal microorganisms within subgingival plaque by Mini Grace scaler (Remove the supragingival plaque with a probe, gently put the sterile Mini Grace scaler into the periodontal pocket)
Description
Subgingival plaque storing: Specimens were collected and placed on ice immediately after sampling, transported to the laboratory within 15min and stored at -80°C. Plaque were conveyed on dry ice to the laboratory at Beijing Allwegene Tech, Ltd (Beijing, China) within 5 h. The microbial genomic DNA was isolated, amplified by PCR, and then the V3-V4 hypervariable regions of the 16S rRNA gene18 were subjected to high-throughput sequencing using the Illumina Miseq PE300 sequencing platform (Illumina, Inc. CA, USA).
Time Frame
Change from Subgingival microbe at 7 days and 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least 18 years old
Previously untreated Stage III and Grade B periodontitis by clinically and radiologically。In 2018, EEP and AAP sorted out periodontitis into four classifications (Stage I to IV) based on several variables including clinical attachment loss, amount and percentage of bone loss, probing depth, presence and extent of angular bony defects and furcation involvement, tooth mobility, and tooth loss due to periodontitis, and three levels (grade A: low risk, grade B: moderate risk, grade C: high risk of progression) according to the rate of disease progression.
A minimum of 20 natural teeth in the mouth, and more than 4 molars.
Exclusion Criteria:
Acute oral lesions or necrotizing ulcerative periodontitis,
Having received antibiotics within 6 months or the need for antibiotic coverage during experiment,
Being allergic to minocycline,
No orthodontic treatment,
A history of systemic diseases,
Pregnancy,
Smoker
12. IPD Sharing Statement
Learn more about this trial
Effects of AMP Application After Non-surgical Periodontal Therapy on Treatment of Periodontitis
We'll reach out to this number within 24 hrs