AzTrials
AzTrials

Gingival PigmentationNCT07521176

Nano Silver Effect in Rapid Wound Healing

A study testing Nano Silver Dressing and Non eugenol zinc oxide Dressing in people with Gingival Pigmentation, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Pigmentation
What is being tested?
Nano Silver Dressing and Non eugenol zinc oxide Dressing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSyria
Study dates
2 Jun 2024to 22 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Syria1 site

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

    Damascus

Other trials in Syria

About this study

Official title: 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.

Read the 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.

Being tested
Nano Silver Dressing, Non eugenol zinc oxide Dressing
Keywords
silver Crystals, Nano, Periodontal dressing, Coe-Pak dressing, Acticoat, Depigmentation, Wound Healing
Medical subject headings
Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nano Silver DressingProcedure or surgery

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

  • Non eugenol zinc oxide DressingProcedure or surgery

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

Study groups in NCT07521176
Study groupRoleWhat they receive
Standard Coe-PAK dressingActive comparatorDe-epithelialization of the melanin-pigmented gingiva was executed with a surgical blade, and the site was covered with the Coe-Pak dressing.
Receives: Procedure: Non eugenol zinc oxide Dressing
Nano Silver dressingExperimentalDe-epithelialization of the melanin-pigmented gingiva was executed with a surgical blade, and the site was covered with the Nano Silver dressing.
Receives: Procedure: Nano Silver Dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wound Healing: Clinical Tissue Healing Index

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

  2. Epithelization: Clinical epithelialization Index

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

Secondary outcomes (2)

  1. Pain Assessment and Analgesic Consumption

    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: Measured daily from day 1 till day 7 postoperatively.

  2. Patient Satisfaction Index (PSI)

    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).

    Measured: recorded for one time one week after the procedure was done

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start2 Jun 2024
  3. Primary completion4 Aug 2025
  4. Study completion22 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A split-mouth design
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07521176
Sponsor's protocol ID
UDDS-2026-Perio-01
Status last verified
Apr 2026
First submitted
31 Mar 2026
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Almeida G, Marques E, De Martin AS, da Silveira Bueno CE, Nowakowski A, Cunha RS. Influence of irrigating solution on postoperative pain following single-visit endodontic treatment: randomized clinical trial. J Can Dent Assoc. 2012;78:c84.

    PubMed 22985896

  • Shrivastava S, Bera T, Roy A, Singh G, Ramachandrarao P, Dash D. Retracted: Characterization of enhanced antibacterial effects of novel silver nanoparticles. Nanotechnology. 2007 May 4;18(22). doi: 10.1088/0957-4484/18/22/225103.

    PubMed 37016550

  • Thirumurugan G, Veni VS, Ramachandran S, Rao JV, Dhanaraju MD. Superior wound healing effect of topically delivered silver nanoparticle formulation using eco-friendly potato plant pathogenic fungus: synthesis and characterization. J Biomed Nanotechnol. 2011 Oct;7(5):659-66. doi: 10.1166/jbn.2011.1336.

    PubMed 22195483

  • Gunasekaran T, Nigusse T, Dhanaraju MD. Silver nanoparticles as real topical bullets for wound healing. J Am Coll Clin Wound Spec. 2012 Jun 4;3(4):82-96. doi: 10.1016/j.jcws.2012.05.001. eCollection 2011 Dec.

    PubMed 24527370

  • Nadworny PL, Wang J, Tredget EE, Burrell RE. Anti-inflammatory activity of nanocrystalline silver-derived solutions in porcine contact dermatitis. J Inflamm (Lond). 2010 Feb 19;7:13. doi: 10.1186/1476-9255-7-13.

    PubMed 20170497

  • Hurd T, Woodmansey EJ, Watkins HMA. A retrospective review of the use of a nanocrystalline silver dressing in the management of open chronic wounds in the community. Int Wound J. 2021 Dec;18(6):753-762. doi: 10.1111/iwj.13576. Epub 2021 Mar 3.

    PubMed 33660375

  • Aggarwal K, Gupta S, Sood S, Bhardwaj SB, Prashar S, Jain A. Effect of nano-crystalline silver membrane on early wound healing after periodontal surgery: A comparative randomized study. J Indian Soc Periodontol. 2021 Nov-Dec;25(6):504-509. doi: 10.4103/jisp.jisp_17_21. Epub 2021 Nov 1.

    PubMed 34898916

Questions about this trial

What is this clinical trial studying?

A study testing Nano Silver Dressing and Non eugenol zinc oxide Dressing in people with Gingival Pigmentation, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wound Healing: Clinical Tissue Healing Index (time frame: Measured weekly, one week postoperatively until week 4 (measured 4 times).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07521176, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

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