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

Beijing Stomatological Hospital, Capital Medical University

Status and phase: Completed; Phase 4

Conditions: Periodontitis

Treatments: Drug: Oral biological antimicrobial gel; Other: SRP; Drug: minocycline hydrochloride ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT05530252

CMUSH-IRB-KJ-PJ-2018-03

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 3 patient groups

AMP Group

Experimental group

Description:

scaling and root planning and subgingival application of antimicrobial peptide gel

Treatment:

Drug: Oral biological antimicrobial gel

Perio Group

Active Comparator group

Description:

scaling and root planning and subgingival application of minocycline hydrochloride ointment

Treatment:

Drug: minocycline hydrochloride ointment

SRP Group

Other group

Description:

scaling and root planning

Treatment:

Other: SRP