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

NCT05530252 | Completed Phase 4 Results

• 1 other identifier: CMUSH-IRB-KJ-PJ-2018-03
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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. 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.

  Change from Bleeding index at 90 days

Study Arms (3)

AMP Group

EXPERIMENTAL

scaling and root planning and subgingival application of antimicrobial peptide gel

Drug: Oral biological antimicrobial gel

Perio Group

ACTIVE COMPARATOR

scaling and root planning and subgingival application of minocycline hydrochloride ointment

Drug: minocycline hydrochloride ointment

SRP Group

OTHER

scaling and root planning

Other: SRP

Interventions

Oral biological antimicrobial gel 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.

Also known as: Biokiller Oral Biological Antimicrobial Gel

AMP Group

minocycline hydrochloride ointment 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.

Also known as: Periocline

Perio Group

SRP OTHER

only scaling and root planning was performed on the patient

SRP Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Stomatological Hospital, Capital Medical University: lead

Study Sites (1)

BeijingSHCMU

Beijing, China

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr.Nannan Han
• Organization: BeijingSHCMU

qhddenver@126.com

15701545851

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients did not know their group or the drugs they were given
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: September 5, 2022
• Primary Completion: December 30, 2022
• Study Completion: January 30, 2023
• Last Updated: April 30, 2024
• Results First Posted: April 30, 2024

Record last verified: 2024-04

Locations

CN (1)