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Clinical Trials/NCT05530252
NCT05530252CompletedPhase 4

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

Beijing Stomatological Hospital, Capital Medical University1 site in 1 country51 target enrollmentStarted: September 5, 2022Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
51
Locations
1
Primary Endpoint
Periodontal Probing Depth

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

The patients did not know their group or the drugs they were given

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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,

Arms & Interventions

AMP Group

Experimental

scaling and root planning and subgingival application of antimicrobial peptide gel

Intervention: Oral biological antimicrobial gel (Drug)

Perio Group

Active Comparator

scaling and root planning and subgingival application of minocycline hydrochloride ointment

Intervention: minocycline hydrochloride ointment (Drug)

SRP Group

Other

scaling and root planning

Intervention: SRP (Other)

Outcomes

Primary Outcomes

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)

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

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. 1. = normal appearance of the gingiva but bleeding on probing of the sulcus. 2. = bleeding on probing and gingival color change without swelling. 3. = bleeding on probing, gingival color change with mild swelling. 4. = bleeding on probing with marked gingival swelling, with or without color change. 5. = bleeding on probing, L Spontaneous bleeding, gingival color change with marked swelling, with or without ulceration.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Beijing Stomatological Hospital, Capital Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yongmei Xie

Principal Investigator

Beijing Stomatological Hospital, Capital Medical University

Study Sites (1)

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