Chronic Periodontitis Clinical Trial
Official title:
Clinical, Microbiological and Biochemical Effectiveness of Full-mouth Treatment Approaches in Severe Chronic Periodontitis: a Randomized Controlled Trial.
NCT number | NCT04038801 |
Other study ID # | FMD |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2006 |
Est. completion date | May 30, 2008 |
Verified date | January 2020 |
Source | Aydin Adnan Menderes University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aimed to compare the effects of full-mouth disinfection (FMD) and full-mouth ultrasonic debridement (FMUD) on clinical, microbiologic and biochemical parameters with conventional quadrant-wise scaling and root planning (Q-SRP) in patients with severe chronic periodontitis. 60 patients with severe chronic periodontitis were randomly allocated to three groups: FMD (n=20), FMUD (n=20) and Q-SRP (n=20). At baseline, gingival crevicular fluid (GCF) and subgingival plaque were collected and clinical periodontal parameters were recorded. Ultrasonic debridement was completed within 24 hours in FMD and FMUD groups. Chlorhexidine gluconate was used for FMD. Q-SRP was performed by hand instruments per quadrant at 1-week-intervals. Clinical parameters were recorded and samples were collected at 1, 3, 6 months after treatment. Real-time PCR was used for quantitative analysis of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia, Fusobacterium nucleatum and total bacteria count. Calprotectin, osteocalcin and cross-linked N-telopeptide of type I collagen (NTx) levels in GCF were analysed by enzyme-linked immunosorbent assay.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 30, 2008 |
Est. primary completion date | May 30, 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 35 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. aged =35 years 2. non-smokers 3. having at least 15 natural teeth. Exclusion Criteria: 1. having any diagnosed medical disorder. 2. taken antibiotics, non-steroidal anti-inflammatory drugs, immunosuppressants, beta-blockers, calcium channel blockers within the past 6 months. 3. patients with a history of sensitivity to chlorhexidine. 4. nonsurgical/surgical periodontal treatment received in the past year 5. having a restorative and endodontic therapy requirement 6. having a removable partial denture and/or orthodontic appliances 7. current pregnancy or lactation. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Aydin Adnan Menderes University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | GCF calprotectin | Calprotectin (pg) levels in GCF. | Change from baseline to 1, 3 and 6 months after treatment. | |
Primary | GCF osteocalcin | Osteocalcin (ng) levels in GCF. | Change from baseline to 1,3 and 6 months after treatment. | |
Primary | GCF NTx | NTx (nM BCE) levels in GCF. | Change from baseline to 1,3 and 6 months after treatment. |
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