Effects of Antimicrobial Peptides Application After Non-surgical Periodontal Therapy on Treatment of Stage III and Grade B Periodontitis
Overview
- Phase
- Phase 4
- Intervention
- Oral biological antimicrobial gel
- Conditions
- Periodontitis
- Sponsor
- Beijing Stomatological Hospital, Capital Medical University
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Periodontal Probing Depth
- Status
- Completed
- Last Updated
- 2 years ago
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.
Investigators
Yongmei Xie
Principal Investigator
Beijing Stomatological Hospital, Capital Medical University
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,
Arms & Interventions
AMP Group
scaling and root planning and subgingival application of antimicrobial peptide gel
Intervention: Oral biological antimicrobial gel
Perio Group
scaling and root planning and subgingival application of minocycline hydrochloride ointment
Intervention: minocycline hydrochloride ointment
SRP Group
scaling and root planning
Intervention: SRP
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.