- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07521176
Nano Silver Effect in Rapid Wound Healing
Evaluation of the Efficacy of Applying the Nano-crystalline Silver Membrane After Surgical Gingival Depigmentation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Damascus, Syria
- Damascus University, Faculty of Dentistry, Department of periodontology.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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A standard Non eugenol zinc oxide Dressing "Coe-PAK®" was applied after the surgical removal of gingival melanin pigmentation
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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.
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A Nano Silver Dressing was Applied After the surgical removal of gingival melanin pigmentation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Wound Healing: Clinical Tissue Healing Index
Time Frame: Measured weekly, one week postoperatively until week 4 (measured 4 times).
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The Tissue Healing Index was evaluated weekly for a total of four weeks postoperatively, according to the following five grades:
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Measured weekly, one week postoperatively until week 4 (measured 4 times).
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Epithelization: Clinical epithelialization Index
Time Frame: Measured weekly, one week postoperatively until week 4 (measured 4 times).
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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:
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Measured weekly, one week postoperatively until week 4 (measured 4 times).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Assessment and Analgesic Consumption
Time Frame: Measured daily from day 1 till day 7 postoperatively.
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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:
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Measured daily from day 1 till day 7 postoperatively.
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Patient Satisfaction Index (PSI)
Time Frame: recorded for one time one week after the procedure was done
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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).
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recorded for one time one week after the procedure was done
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Collaborators and Investigators
Sponsor
Investigators
- 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
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UDDS-2026-Perio-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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