Surfactant Protein D Levels in GCF Before and After MINST in Periodontitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University
About this trial
This study will evaluate changes in Surfactant Protein D (SP-D) levels in gingival crevicular fluid (GCF) of patients with periodontitis before and after minimally invasive non-surgical periodontal therapy (MINST).
Participants diagnosed with stage II or III periodontitis will receive minimally invasive non-surgical periodontal treatment. GCF samples will be collected at baseline and 6 months after treatment, and SP-D levels will be measured using enzyme-linked immunosorbent assay (ELISA).
The study will also assess clinical periodontal outcomes, including full-mouth plaque score, full-mouth bleeding score, probing pocket depth, clinical attachment level, gingival recession, and patient satisfaction. Each participant will serve as their own control by comparing baseline values with 6-month post-treatment values.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female participants aged 18 years or older.
Diagnosis of periodontitis, classified as stage II or stage III according to the 2018 classification system.
Presence of at least one tooth with probing pocket depth (PPD) of 5 mm or more, clinical attachment loss (CAL), and radiographic evidence of bone loss.
Presence of at least one intrabony defect with a radiographic intrabony component measuring 3 mm or more.
Disqualifiers
Current smokers or individuals with a history of smoking within the past year.
Pregnant or lactating women.
Use of systemic antibiotics or anti-inflammatory medications within the last 3 months.
Known allergy to any materials or agents used during periodontal therapy.
Trial design
Design model
Single group
Treatments tested in this trial
Minimally Invasive Non-Surgical Periodontal Therapy
Procedure/SurgeryMinimally invasive non-surgical periodontal therapy will include oral hygiene instructions, supragingival plaque control, and subgingival instrumentation using fine periodontal instruments, miniature Gracey curettes, thin ultrasonic tips, magnification when available, and local anesthesia when needed. Debridement will be performed for periodontal pockets while minimizing trauma to the soft tissues.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: MINST GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Surfactant Protein D (SP-D) Levels in Gingival Crevicular Fluid
Change in Surfactant Protein D (SP-D) concentration in gingival crevicular fluid from baseline to 6 months after minimally invasive non-surgical periodontal therapy. SP-D levels will be measured using enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL.
Time frame
Baseline and 6 months after treatmentSecondary outcomes
1
Change in Full-Mouth Plaque Score
Change in full-mouth plaque score from baseline to 6 months after treatment. Plaque score will be recorded as the percentage of sites with visible plaque.
Time frame
Baseline and 6 months after treatment2
Change in Probing Pocket Depth
Change in probing pocket depth from baseline to 6 months after treatment. Probing pocket depth will be measured in millimeters using a UNC-15 periodontal probe.
Time frame
Baseline and 6 months after treatment3
Change in Clinical Attachment Level
Change in clinical attachment level from baseline to 6 months after treatment. Clinical attachment level will be measured in millimeters using a UNC-15 periodontal probe.
Time frame
Baseline and 6 months after treatment4
Change in Gingival Recession
Change in gingival recession from baseline to 6 months after treatment. Gingival recession will be measured in millimeters from the cemento-enamel junction to the gingival margin using a UNC-15 periodontal probe.
Time frame
Baseline and 6 months after treatmentSponsors and contacts
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Source ClinicalTrials.gov