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

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

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Drug: Oral biological antimicrobial gel; Drug: minocycline hydrochloride ointment; Other: SRP

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • BeijingSHCMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMP Group; scaling and root planning and subgingival application of antimicrobial peptide gel	Drug: Oral biological antimicrobial gel; 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
Active Comparator: Perio Group; scaling and root planning and subgingival application of minocycline hydrochloride ointment	Drug: minocycline hydrochloride ointment; 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
Other: SRP Group; scaling and root planning	Other: SRP; only scaling and root planning was performed on the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal Probing Depth	from the gingival margin to the bottom of the periodontal pocket were assessed using a Williams periodontal probe((Hu-Friedy)	Change from Baseline Periodontal probing depth at 90 days
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	Change from Baseline Attachment level at 90 days
Bleeding Index Were Assessed Using a Williams Periodontal Probe((Hu-Friedy) ,the Rating Method Was Assessed Using the Criteria of Mazza.	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.	Change from Bleeding index at 90 days

Collaborators and Investigators

• Sponsor: Beijing Stomatological Hospital, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 3, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Estimated): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Anti-Bacterial Agents; Anti-Infective Agents; Minocycline
• Other Study ID Numbers: CMUSH-IRB-KJ-PJ-2018-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No