Ondokuz Mayıs University Faculty of Dentistry
Samsun, Atakum, 55200, Turkey (Türkiye)
NCT Number: NCT07672587
This randomized controlled clinical trial aimed to compare the effectiveness of different treatment approaches for physiologic gingival hyperpigmentation. Participants with gingival melanin pigmentation were randomly assigned to one of four treatment groups: Er:YAG laser treatment, air polishing with erythritol powder, air polishing with sodium bicarbonate powder, or conventional surgical excision. Clinical outcomes were evaluated using pigmentation index scores, digital image analysis, and color measurements at baseline and follow-up visits. Patient-centered outcomes, including postoperative discomfort and satisfaction, were also assessed. The study sought to determine whether air polishing techniques could provide clinical outcomes comparable to conventional treatment approaches while improving patient comfort and satisfaction.
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Samsun, Atakum, 55200, Turkey (Türkiye)
Physiologic gingival hyperpigmentation is a common esthetic condition caused by excessive melanin deposition within the gingival epithelium. Several treatment approaches have been proposed to eliminate gingival pigmentation, including conventional surgical techniques, laser applications, and minimally invasive air polishing systems. Although conventional surgical excision and laser therapy are widely used, alternative approaches that may reduce postoperative discomfort while maintaining comparable clinical outcomes remain of clinical interest.
The purpose of this randomized controlled clinical trial was to compare the clinical effectiveness and patient-related outcomes of four different treatment modalities for gingival hyperpigmentation: Er:YAG laser treatment, air polishing with erythritol powder, air polishing with sodium bicarbonate powder, and conventional surgical excision.
Eligible participants diagnosed with physiologic gingival melanin hyperpigmentation were randomly allocated into four parallel treatment groups. Clinical pigmentation changes were assessed using standardized clinical photographs, pigmentation index scoring systems, digital color analysis, and quantitative color measurements during baseline and follow-up examinations over a three-month period. Secondary evaluations included postoperative discomfort assessment and patient satisfaction measurements.
The study was designed to evaluate whether minimally invasive air polishing approaches could achieve clinical outcomes comparable to established treatment methods while providing improved patient comfort during the healing period.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Gingival depigmentation was performed using Er:YAG laser therapy to remove physiologic gingival melanin pigmentation. The procedure was applied according to the manufacturer's recommended clinical protocol for soft tissue ablation.
Gingival depigmentation was performed using an air polishing system with erythritol powder to remove physiologic gingival melanin pigmentation. The procedure was carried out by applying pressurized air and powder particles to the pigmented gingival surface according to the treatment protocol.
Gingival depigmentation was performed using an air polishing system with sodium bicarbonate powder to remove physiologic gingival melanin pigmentation. The procedure was carried out by applying pressurized air and powder particles to the pigmented gingival surface according to the treatment protocol.
Gingival depigmentation was performed using a conventional surgical excision technique for the removal of physiologic gingival melanin pigmentation. The procedure involved surgical removal of the pigmented gingival epithelium using conventional periodontal surgical instruments according to standard clinical practice.
Time frame: Baseline, 7 days after treatment, 1 month after treatment, and 3 months after treatment
Changes in gingival color will be quantitatively assessed using standardized digital photographs and RGB color analysis following depigmentation procedures.
Time frame: 7 days after treatment, 1 month after treatment, and 3 months after treatment
Gingival color change following treatment will be evaluated by calculating color difference values using the Delta E (CIE76) formula based on digital photographic analysis.
Time frame: Baseline, 7 days after treatment, 1 month after treatment, and 3 months after treatment
The extent of gingival pigmentation will be quantitatively assessed by measuring the pigmented gingival area from standardized digital photographs.
Time frame: Baseline, 1 months after treatment, 3 months after treatment
Gingival pigmentation intensity will be clinically evaluated using the Dummett Oral Pigmentation Index (DOPI) to assess treatment effectiveness.
Time frame: Day 1 after treatment, Day 3 after treatment, and Day 7 after treatment
Postoperative pain associated with each treatment procedure will be assessed using the Visual Analog Scale (VAS).
Time frame: Baseline, 3 months after treatment
Patient satisfaction regarding esthetic treatment outcomes will be evaluated using a Visual Analog Scale (VAS).
Time frame: Baseline, 1 months after treatment, 3 months after treatment
Esthetic treatment outcomes will be independently evaluated by blinded clinicians to assess overall esthetic improvement after treatment.
Ondokuz Mayıs University
Other
Comparison of Laser, Guided Biofilm Therapy, and Conventional Surgical Approaches in the Treatment of Gingival Hyperpigmentation: Evaluation of Clinical Outcomes and Patient Satisfaction
Acronym: APGH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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