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NCT Number: NCT05530252

Effects of AMP Application After Non-surgical Periodontal Therapy on Treatment of Periodontitis

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

BeijingSHCMU

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral biological antimicrobial gel

Drug

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.

Other names: Biokiller Oral Biological Antimicrobial Gel

minocycline hydrochloride ointment

Drug

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.

Other names: Periocline

SRP

Other

only scaling and root planning was performed on the patient

Primary outcomes

  1. Periodontal Probing Depth

    Time frame: Change from Baseline Periodontal probing depth at 90 days

    from the gingival margin to the bottom of the periodontal pocket were assessed using a Williams periodontal probe((Hu-Friedy)

  2. Attachment Level Were Assessed Using a Williams Periodontal Probe((Hu-Friedy)

    Time frame: Change from Baseline Attachment level at 90 days

    from the cementoenamel junction, crown margin or restoration to the bottom of the pocket

  3. Bleeding Index Were Assessed Using a Williams Periodontal Probe((Hu-Friedy) ,the Rating Method Was Assessed Using the Criteria of Mazza.

    Time frame: Change from Bleeding index at 90 days

    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.

Sponsors and collaborators

Lead sponsor

Beijing Stomatological Hospital, Capital Medical University

Other

Registry information

Official study title

Effects of Antimicrobial Peptides Application After Non-surgical Periodontal Therapy on Treatment of Stage III and Grade B Periodontitis

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Sep 7, 2022
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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