PeriodontitisPhase 4NCT05530252
Effects of AMP Application After Non-surgical Periodontal Therapy on Treatment of Periodontitis
A Phase 4 study testing Oral biological antimicrobial gel, minocycline hydrochloride ointment and SRP in people with Periodontitis, run by Beijing Stomatological Hospital, Capital Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Oral biological antimicrobial gel, minocycline hydrochloride ointment and SRP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2022to 30 Jan 2023
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Antimicrobial Peptides Application After Non-surgical Periodontal Therapy on Treatment of Stage III and Grade B Periodontitis
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
- Being tested
- Oral biological antimicrobial gel, minocycline hydrochloride ointment, SRP
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral biological antimicrobial gelDrug
Also called Biokiller 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.
minocycline hydrochloride ointmentDrug
Also called Periocline
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.
SRPOther
only scaling and root planning was performed on the patient
| Study group | Role | What they receive |
|---|---|---|
| AMP Group | Experimental | scaling and root planning and subgingival application of antimicrobial peptide gel Receives: Drug: Oral biological antimicrobial gel |
| Perio Group | Active comparator | scaling and root planning and subgingival application of minocycline hydrochloride ointment Receives: Drug: minocycline hydrochloride ointment |
| SRP Group | Other | scaling and root planning Receives: Other: SRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal Probing Depth
from the gingival margin to the bottom of the periodontal pocket were assessed using a Williams periodontal probe((Hu-Friedy)
Measured: 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
Measured: 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.
- = normal appearance of the gingiva but bleeding on probing of the sulcus.
- = bleeding on probing and gingival color change without swelling.
- = bleeding on probing, gingival color change with mild swelling.
- = bleeding on probing with marked gingival swelling, with or without color change.
- = bleeding on probing, L Spontaneous bleeding, gingival color change with marked swelling, with or without ulceration.
Measured: Change from Bleeding index at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start5 Sep 2022
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Stomatological Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongmei Xie, Beijing Stomatological Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530252
- Sponsor's protocol ID
- CMUSH-IRB-KJ-PJ-2018-03
- Status last verified
- Apr 2024
- First submitted
- 2 Sep 2022
- Last updated
- 30 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No