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Completed

NCT Number: NCT07521176

Nano Silver Effect in Rapid Wound Healing

Silver compounds have demonstrated a positive effect in most medical fields, including periodontal therapy, particularly in their nano-formulations. These nanoparticles have exhibited a significant capacity to accelerate healing and possess antibacterial and anti-inflammatory properties, in addition to their ability to mitigate pain and postoperative complications.

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Key information

Conditions

Gingival Pigmentation Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases Vitiligo

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University, Faculty of Dentistry, Department of periodontology.

Damascus, Syria

About this study

The objective of the current study was to evaluate tissue healing, epithelialization, postoperative pain, degree of pigmentation, and patient satisfaction following the application of a nano-silver crystal membrane compared to conventional dressing after the surgical removal of gingival melanin pigmentation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gingival Hyperpigmentation: Presence of physiological melanin pigmentation in the maxillary anterior region, categorized as Grade 3 or 4 according to the Heden Gingival Pigmentation Index.
  • Age Demographic: Patients aged 20 years or older.
  • Periodontal Health: Absence of active periodontal disease (e.g., periodontitis or gingivitis).
  • Gingival Biotype: Presence of a medium-to-thick gingival biotype.
  • Attached Gingiva: An adequate width of attached gingiva to ensure surgical stability.
  • Oral Hygiene: Demonstration of good oral hygiene with a proven ability to maintain effective plaque control throughout the study period.

Exclusion criteria

  • Systemic Pigmentation: Presence of gingival discoloration secondary to systemic conditions or metabolic disorders.
  • Drug-Induced Pigmentation: Hyperpigmentation resulting from the administration of specific pharmacological agents.
  • Poor Oral Hygiene: Inadequate plaque control or a lack of compliance with oral self-care instructions.
  • Smoking Status: Current smokers or individuals with a recent history of tobacco use, due to its confounding effect on gingival pigmentation and wound healing.
  • Physiological Status: Pregnant or lactating women.
  • Systemic Health & Medication: Patients with underlying systemic diseases or those receiving medications known to influence periodontal tissue integrity or inflammatory response (e.g., immunosuppressants or calcium channel blockers).
  • Periodontal Disease: Presence of active periodontitis or attachment loss.

Treatment and study plan

Nano Silver Dressing

Procedure

A Nano Silver Dressing was Applied After the surgical removal of gingival melanin pigmentation

Non eugenol zinc oxide Dressing

Procedure

A standard Non eugenol zinc oxide Dressing "Coe-PAK®" was applied after the surgical removal of gingival melanin pigmentation

Primary outcomes

  1. Wound Healing: Clinical Tissue Healing Index

    Time frame: Measured weekly, one week postoperatively until week 4 (measured 4 times).

    The Tissue Healing Index was evaluated weekly for a total of four weeks postoperatively, according to the following five grades:

    • Grade 1 (Very Poor): Redness (>50%), granulation, bleeding, and pus present.
    • Grade 2 (Poor): Redness (>50%), granulation, and bleeding present; no pus.
    • Grade 3 (Good): Redness (<50%), no granulation, no bleeding, and no exposed connective tissue.
    • Grade 4 (Very Good): Redness (<25%), no granulation, no bleeding, and no exposed connective tissue.
    • Grade 5 (Excellent): Healthy pink tissue, no bleeding, and complete marginal closure.

  2. Epithelization: Clinical epithelialization Index

    Time frame: Measured weekly, one week postoperatively until week 4 (measured 4 times).

    Re-epithelialization was assessed weekly for a total of four weeks postoperatively using 1% Toluidine Blue. Deep blue staining identifies denuded connective tissue, while pale blue indicates complete healing. The clinical scale is as follows:

    • Grade 1: No epithelial formation.
    • Grade 2: Partial coverage (less than 50%).
    • Grade 3: Substantial coverage (more than 50%).
    • Grade 4: Complete re-epithelialization.

Secondary outcomes

  1. Pain Assessment and Analgesic Consumption

    Time frame: Measured daily from day 1 till day 7 postoperatively.

    Daily postoperative pain was recorded for one week using a 100-mm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (unbearable). Scores were categorized as:

    • 1-30 mm: Mild pain.
    • 31-60 mm: Moderate pain.
    • 61-100 mm: Severe pain. Daily analgesic intake was also documented to supplement these subjective findings.

  2. Patient Satisfaction Index (PSI)

    Time frame: recorded for one time one week after the procedure was done

    This qualitative metric categorizes the patient's subjective perception of the surgical outcome into four distinct grades. For analytical purposes, scores were dichotomized into 'Satisfied' (Grades 1-2) and 'Dissatisfied' (Grades 3-4).

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of the Efficacy of Applying the Nano-crystalline Silver Membrane After Surgical Gingival Depigmentation

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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