Clinical trial NCT05530252: Effects of AMP Application After Non-surgical Periodontal Therapy on Treatment of Periodontitis
Official title: Effects of Antimicrobial Peptides Application After Non-surgical Periodontal Therapy on Treatment of Stage III and Grade B Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontitis
Lead sponsor: Beijing Stomatological Hospital, Capital Medical University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Periodontal Probing Depth
timeFrame: Change from Baseline Periodontal probing depth at 90 days
measure: Attachment Level Were Assessed Using a Williams Periodontal Probe((Hu-Friedy)
timeFrame: Change from Baseline Attachment level at 90 days
measure: Bleeding Index Were Assessed Using a Williams Periodontal Probe((Hu-Friedy) ,the Rating Method Was Assessed Using the Criteria of Mazza.
timeFrame: Change from Bleeding index at 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: BeijingSHCMU
Study officials:
References: