Gingival Pigmentation
Conditions
Keywords
silver Crystals, Nano, Periodontal dressing, Coe-Pak dressing, Acticoat, Depigmentation, Wound Healing
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.
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.
Interventions
PROCEDURENano Silver Dressing
A Nano Silver Dressing was Applied After the surgical removal of gingival melanin pigmentation
PROCEDURENon eugenol zinc oxide Dressing
A standard Non eugenol zinc oxide Dressing "Coe-PAK®" was applied after the surgical removal of gingival melanin pigmentation
Sponsors
Damascus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
A split-mouth design
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing: Clinical Tissue Healing Index | 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. |
| Epithelization: Clinical epithelialization Index | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessment and Analgesic Consumption | 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. |
| Patient Satisfaction Index (PSI) | 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). |
Countries
Syria
Contacts
STUDY_CHAIRTarek A Qasim, DDS MSc PhD
Damascus University, Faculty of Dentistry, Department of Periodontology
PRINCIPAL_INVESTIGATORAra V Seferian, DDS
Damascus University, Faculty of Dentistry, Department of Periodontology
Outcome results
None listed