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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
Beijing Stomatological Hospital, Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 2, 2022
    Last Updated
    September 14, 2022
    Sponsor
    Beijing Stomatological Hospital, Capital Medical University
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    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

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