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

NCT ID: NCT05530252

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-05
• Study Completion Date: 2023-01-30

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.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AMP Group

scaling and root planning and subgingival application of antimicrobial peptide gel

Group Type: EXPERIMENTAL

Oral biological antimicrobial gel

Intervention Type: 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with gel was inserted into the periodontal pocket, and the injection was slowly pushed, and the injection was gradually withdrawn during the injection, until a little gel was found at the mouth of the bag.

Perio Group

scaling and root planning and subgingival application of minocycline hydrochloride ointment

Group Type: ACTIVE_COMPARATOR

minocycline hydrochloride ointment

Intervention Type: 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.

SRP Group

scaling and root planning

Group Type: OTHER

SRP

Intervention Type: OTHER

only scaling and root planning was performed on the patient

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

SRP

only scaling and root planning was performed on the patient

Intervention Type: OTHER

Other Intervention Names

Biokiller Oral Biological Antimicrobial Gel; Periocline

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,
• Smoker

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Stomatological Hospital, Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yongmei Xie

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

BeijingSHCMU

Beijing, , China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CMUSH-IRB-KJ-PJ-2018-03

Identifier Type: -

Identifier Source: org_study_id