Actively Recruiting
Comparing Different Timings for Periodontal Re-evaluation After Non-surgical Periodontal Therapy (NSPT)
Led by University of Parma · Updated on 2025-04-17
52
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying periodontitis, a gum disease, to compare how the timing of periodontal re-evaluation after non-surgical periodontal therapy (NSPT) affects healing. The study specifically looks at the percentage of closed gum pockets, defined as pocket depth less than 5 mm with no bleeding on probing. This prospective cohort study will recruit 52 adults aged 18 and older who are otherwise healthy and have periodontitis. The investigation follows established clinical trial reporting standards. Participants will receive NSPT following minimally invasive principles, where hard and soft deposits are carefully removed using ultrasonic instruments. Treatment is organized into 2 to 4 sessions, spaced about a week apart, targeting infected gum areas. If needed, hopeless teeth may be extracted during this phase. The study includes seven visits over 15 months, with re-evaluations at 3-4, 6-8, and 12 months after therapy to measure gum pocket status and other oral health indicators. Throughout the study, participants will undergo thorough periodontal assessments by trained examiners at multiple timepoints, including full-mouth measurements of pocket depths, bleeding, plaque, and gum recession. Additional procedures include saliva and fluid collection from gum pockets, 3D intra-oral scans, X-rays, and questionnaires about oral health and quality of life. Oral hygiene instructions and teeth polishing are reinforced regularly. Safety and medical history updates are collected at each visit. The main outcome measured is the change in the percentage of closed pockets from baseline to each follow-up timepoint.
CONDITIONS
Brief Title
Comparing Different Timings for Periodontal Re-evaluation After Non-surgical Periodontal Therapy (NSPT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Systemically healthy males and females
- Willingness to read and sign informed consent after study explanation
- Clinical evidence of periodontitis with attachment loss at 2 or more non-adjacent teeth or attachment loss 3 mm with pocketing >3 mm at 2 or more teeth
- No subgingival instrumentation in the past 12 months
You will not qualify if you...
- Serious medical conditions or transmittable diseases such as cardiovascular disease, organ transplant, renal failure, AIDS, or viral infections
- Antibiotic, anti-inflammatory, or anticoagulant therapy within 1 month before baseline exam
- Treatment with drugs that cause gingival overgrowth
- History of conditions requiring prophylactic antibiotics before dental procedures
- History of alcohol or drug abuse
- Pregnancy or lactation
- Severe acute or chronic medical or psychiatric conditions or lab abnormalities that increase risk or interfere with study participation or results
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 days from baseline
Participants receive non-surgical periodontal therapy (NSPT) involving the removal of hard and soft deposits at infected sites, performed over multiple sessions using a quadrant approach.
2 to 4 visits (in-person) within 60 days from baseline
Duration - 4 to 6 weeks from the end of NSPT
Participants undergo a follow-up visit for visual inspection, supragingival polishing, oral hygiene reinforcement, and collection of patient-reported outcomes.
1 visit (in-person)
Duration - 3 to 4 months from the end of NSPT
Participants receive a periodontal assessment and supportive care including polishing, oral hygiene instruction, and collection of saliva and gingival crevicular fluid samples.
1 visit (in-person)
Duration - 6 to 8 months from the end of NSPT
Participants receive a periodontal assessment and supportive care including polishing, oral hygiene instruction, and collection of saliva and gingival crevicular fluid samples.
1 visit (in-person)
Duration - 12 months ± 14 days from the end of NSPT
Participants receive a final periodontal assessment including x-rays, polishing, oral hygiene instruction, and collection of saliva and gingival crevicular fluid samples.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Centro Universitario di Odontoiatria
Parma, Italy
Actively Recruiting
Research Team
E
Elena Calciolari, DDS, MS, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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