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

NCT07599657 | Recruiting DMC

• 1 other identifier: PER 7-2-1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis; Periodontitis Stage II; Periodontitis Stage III

Keywords

Surfactant Protein D; Gingival Crevicular Fluid; ELISA; Periodontal Biomarker; Non-Surgical Periodontal Therapy; MINST; Minimally Invasive Non-Surgical Periodontal Therapy; Periodontitis; GCF; SP-D

Outcome Measures

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.

  Baseline and 6 months after treatment

Secondary Outcomes (5)

• Change in Full-Mouth Plaque Score

  Baseline and 6 months after treatment

• Change in Probing Pocket Depth

  Baseline and 6 months after treatment

• Change in Clinical Attachment Level

  Baseline and 6 months after treatment

• Change in Gingival Recession

  Baseline and 6 months after treatment

• Patient Satisfaction Score

  6 months after treatment

Study Arms (1)

MINST Group

EXPERIMENTAL

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

Interventions

Minimally Invasive Non-Surgical Periodontal Therapy PROCEDURE

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.

Also known as: MINST

MINST Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Hossam Ashraf ElMasry

CONTACT

+201129559757; hossam.eldamarany@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Laboratory personnel measuring SP-D levels using ELISA will be blinded to the timing of sample collection, whether baseline or 6 months after treatment. Data analysts will also be blinded to the timing of sample collection. Participants and clinicians cannot be blinded because of the nature of the periodontal intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University

Model Details: Single-group before-and-after interventional clinical study. Participants diagnosed with periodontitis will receive minimally invasive non-surgical periodontal therapy. Clinical periodontal parameters and gingival crevicular fluid SP-D levels will be assessed at baseline and 6 months after treatment. Each participant will serve as their own control.

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

EG (1)