Surfactant Protein D Levels in GCF Before and After MINST in Periodontitis

Evaluation of Surfactant Protein D (SP-D) Levels in the GCF of Periodontitis Patients Associated With the Endpoints After Minimally Invasive Non-surgical Periodontal Therapy: A Before and After Study

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis; Periodontitis Stage II; Periodontitis Stage III
• Intervention / Treatment: Procedure: Minimally Invasive Non-Surgical Periodontal Therapy

Detailed Description

Periodontitis is a chronic multifactorial inflammatory disease characterized by progressive destruction of the supporting periodontal tissues. Conventional clinical parameters, such as probing pocket depth, bleeding on probing, and clinical attachment level, are useful for diagnosis and follow-up but may reflect tissue destruction after it has already occurred. Therefore, biomarkers that reflect the biological inflammatory status of periodontal tissues may improve monitoring of disease activity and treatment response.

Surfactant Protein D (SP-D) is an innate immune molecule involved in host defense and modulation of inflammation. It has been detected in oral fluids, including gingival crevicular fluid, and may be associated with periodontal inflammation. This study aims to evaluate whether SP-D levels in GCF change after minimally invasive non-surgical periodontal therapy in patients with periodontitis.

This is a single-group before-and-after interventional clinical study. Eligible participants with stage II or III periodontitis will be recruited from the outpatient periodontal clinics of the Faculty of Dentistry, Cairo University. At baseline, periodontal clinical parameters will be recorded, including full-mouth plaque score, full-mouth bleeding score, probing pocket depth, clinical attachment level, and gingival recession. GCF samples will be collected from selected periodontal sites using sterile paper strips and stored until biochemical analysis.

All participants will receive minimally invasive non-surgical periodontal therapy, including oral hygiene instructions, supragingival plaque control, and subgingival instrumentation using minimally invasive techniques. Treatment will be performed using fine periodontal instruments, thin ultrasonic tips, magnification when available, and local anesthesia when needed to improve patient comfort and minimize tissue trauma.

After 6 months, participants will be recalled for clinical re-evaluation and collection of post-treatment GCF samples from the same sites. SP-D levels will be measured using ELISA. The primary outcome will be the change in SP-D level from baseline to 6 months after treatment. Secondary outcomes will include changes in plaque score, bleeding score, probing pocket depth, clinical attachment level, gingival recession, and patient satisfaction.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hossam Ashraf ElMasry; Phone Number: +201129559757; Email: hossam.eldamarany@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 12613
    • Recruiting
    • Faculty of Dentistry, Cairo University
    • Contact: Faculty of Dentistry, Cairo University; Phone Number: 01002159535

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MINST Group; Participants diagnosed with periodontitis will receive minimally invasive non-surgical periodontal therapy (MINST). Clinical periodontal parameters and gingival crevicular fluid samples will be collected at baseline and 6 months after treatment to assess changes in SP-D levels and periodontal outcomes.

Procedure: Minimally Invasive Non-Surgical Periodontal Therapy; Minimally 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.; Other Names: MINST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 6 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 6 months after treatment
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.	Baseline and 6 months after treatment
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.	Baseline and 6 months after treatment
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.	Baseline and 6 months after treatment
Patient Satisfaction Score	Patient satisfaction will be assessed at the 6-month follow-up using a standardized 5-point Likert-scale questionnaire. Higher scores indicate greater patient satisfaction.	6 months after treatment

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): May 14, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Periodontitis; ELISA; GCF; MINST; Gingival Crevicular Fluid; SP-D; Non-Surgical Periodontal Therapy; Surfactant Protein D; Periodontal Biomarker; Minimally Invasive Non-Surgical Periodontal Therapy
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis
• Other Study ID Numbers: PER 7-2-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No