Nano Silver Effect in Rapid Wound Healing

April 7, 2026 updated by: Damascus University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syria
      • Damascus, Syria
        • Damascus University, Faculty of Dentistry, Department of periodontology.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 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.
  2. Age Demographic: Patients aged 20 years or older.
  3. Periodontal Health: Absence of active periodontal disease (e.g., periodontitis or gingivitis).
  4. Gingival Biotype: Presence of a medium-to-thick gingival biotype.
  5. Attached Gingiva: An adequate width of attached gingiva to ensure surgical stability.
  6. Oral Hygiene: Demonstration of good oral hygiene with a proven ability to maintain effective plaque control throughout the study period.

Exclusion Criteria:

  1. Systemic Pigmentation: Presence of gingival discoloration secondary to systemic conditions or metabolic disorders.
  2. Drug-Induced Pigmentation: Hyperpigmentation resulting from the administration of specific pharmacological agents.
  3. Poor Oral Hygiene: Inadequate plaque control or a lack of compliance with oral self-care instructions.
  4. Smoking Status: Current smokers or individuals with a recent history of tobacco use, due to its confounding effect on gingival pigmentation and wound healing.
  5. Physiological Status: Pregnant or lactating women.
  6. 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).
  7. Periodontal Disease: Presence of active periodontitis or attachment loss.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard Coe-PAK dressing
De-epithelialization of the melanin-pigmented gingiva was executed with a surgical blade, and the site was covered with the Coe-Pak dressing.
Procedure: Non eugenol zinc oxide Dressing
A standard Non eugenol zinc oxide Dressing "Coe-PAK®" was applied after the surgical removal of gingival melanin pigmentation
Experimental: Nano Silver dressing
De-epithelialization of the melanin-pigmented gingiva was executed with a surgical blade, and the site was covered with the Nano Silver dressing.
Procedure: Nano Silver Dressing
A Nano Silver Dressing was Applied After the surgical removal of gingival melanin pigmentation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Measured weekly, one week postoperatively until week 4 (measured 4 times).
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.
Measured weekly, one week postoperatively until week 4 (measured 4 times).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Measured daily from day 1 till day 7 postoperatively.
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).
recorded for one time one week after the procedure was done

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Damascus University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Tarek A Qasim, DDS MSc PhD, Damascus University, Faculty of Dentistry, Department of Periodontology
  • Principal Investigator: Ara V Seferian, DDS, Damascus University, Faculty of Dentistry, Department of Periodontology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 4, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UDDS-2026-Perio-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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