Periodontitis
Conditions
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.
Interventions
DRUGOral 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with gel was inserted into the periodontal pocket, and the injection was slowly pushed, and the injection was gradually withdrawn during the injection, until a little gel was found at the mouth of the bag.
DRUGminocycline 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with gel was inserted into the periodontal pocket, and the injection was slowly pushed, and the injection was gradually withdrawn during the injection, until a little gel was found at the mouth of the bag.
OTHERSRP
only scaling and root planning was performed on the patient
Sponsors
Beijing Stomatological Hospital, Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The patients did not know their group or the drugs they were given
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periodontal Probing Depth | Change from Baseline Periodontal probing depth at 90 days | from the gingival margin to the bottom of the periodontal pocket were assessed using a Williams periodontal probe((Hu-Friedy) |
| Attachment Level Were Assessed Using a Williams Periodontal Probe((Hu-Friedy) | Change from Baseline Attachment level at 90 days | from the cementoenamel junction, crown margin or restoration to the bottom of the pocket |
| Bleeding Index Were Assessed Using a Williams Periodontal Probe((Hu-Friedy) ,the Rating Method Was Assessed Using the Criteria of Mazza. | Change from Bleeding index at 90 days | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AMP Group scaling and root planning and subgingival application of antimicrobial peptide gel
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. | 17 |
| Perio Group scaling and root planning and subgingival application of minocycline hydrochloride ointment
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. | 17 |
| SRP Group scaling and root planning
SRP: only scaling and root planning was performed on the patient | 17 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | AMP Group | Perio Group | SRP Group | Total |
|---|---|---|---|---|
| Age, Continuous | 38.73 years STANDARD_DEVIATION 14.03 | 37.93 years STANDARD_DEVIATION 12.74 | 38.50 years STANDARD_DEVIATION 10.01 | 38.39 years STANDARD_DEVIATION 10.54 |
| Probing depth | 5.0 millimeter | 4.9 millimeter | 5.0 millimeter | 5.0 millimeter |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 10 Participants | 31 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 7 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 | 0 / 17 |
Outcome results
Primary
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
Time frame: Change from Baseline Attachment level at 90 days
Population: Three subjects did not return to the clinic as required and were not included in the final data analysis of the study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AMP Group | Attachment Level Were Assessed Using a Williams Periodontal Probe((Hu-Friedy) | 1.0 millimeter |
| Perio Group | Attachment Level Were Assessed Using a Williams Periodontal Probe((Hu-Friedy) | 1.7 millimeter |
| SRP Group | Attachment Level Were Assessed Using a Williams Periodontal Probe((Hu-Friedy) | 2.0 millimeter |
Primary
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.
Time frame: Change from Bleeding index at 90 days
Population: Three subjects did not return to the clinic as required and were not included in the final data analysis of the study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AMP Group | Bleeding Index Were Assessed Using a Williams Periodontal Probe((Hu-Friedy) ,the Rating Method Was Assessed Using the Criteria of Mazza. | 0.7 score on a scale |
| Perio Group | Bleeding Index Were Assessed Using a Williams Periodontal Probe((Hu-Friedy) ,the Rating Method Was Assessed Using the Criteria of Mazza. | 1.1 score on a scale |
| SRP Group | Bleeding Index Were Assessed Using a Williams Periodontal Probe((Hu-Friedy) ,the Rating Method Was Assessed Using the Criteria of Mazza. | 1.3 score on a scale |
Primary
Periodontal Probing Depth
from the gingival margin to the bottom of the periodontal pocket were assessed using a Williams periodontal probe((Hu-Friedy)
Time frame: Change from Baseline Periodontal probing depth at 90 days
Population: Three subjects did not return to the clinic as required and were not included in the final data analysis of the study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AMP Group | Periodontal Probing Depth | 2.5 millimeter |
| Perio Group | Periodontal Probing Depth | 3.2 millimeter |
| SRP Group | Periodontal Probing Depth | 3.4 millimeter |