NCT07521176

Brief 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 to mitigate pain and postoperative complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

March 31, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

silver CrystalsNanoPeriodontal dressingCoe-Pak dressingActicoatDepigmentationWound Healing

Outcome Measures

Primary Outcomes (2)

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

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

Secondary Outcomes (2)

  • Pain Assessment and Analgesic Consumption

    Measured daily from day 1 till day 7 postoperatively.

  • Patient Satisfaction Index (PSI)

    recorded for one time one week after the procedure was done

Study Arms (2)

Standard Coe-PAK dressing

ACTIVE COMPARATOR

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

Nano Silver dressing

EXPERIMENTAL

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

Interventions

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

Standard Coe-PAK dressing

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

Nano Silver dressing

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damascus University, Faculty of Dentistry, Department of periodontology.

Damascus, Syria

Location

Related Publications (7)

  • 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.

    PMID: 22985896BACKGROUND
  • 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.

    PMID: 37016550BACKGROUND
  • 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.

    PMID: 22195483BACKGROUND
  • 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.

    PMID: 24527370BACKGROUND
  • 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.

    PMID: 20170497BACKGROUND
  • 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.

    PMID: 33660375BACKGROUND
  • 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.

    PMID: 34898916BACKGROUND

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Tarek A Qasim, DDS MSc PhD

    Damascus University, Faculty of Dentistry, Department of Periodontology

    STUDY CHAIR
  • Ara V Seferian, DDS

    Damascus University, Faculty of Dentistry, Department of Periodontology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A split-mouth design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 9, 2026

Study Start

June 2, 2024

Primary Completion

August 4, 2025

Study Completion

December 22, 2025

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations