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Objective: To evaluate the effectiveness of a gel containing nanovitamin C, nanovitamin E and propolis extract compared to a placebo in the treatment of desquamative gingivitis (GD) in patients with mucocutaneous diseases with gingival involvement. The possible improvement in the quality of life of these patients after treatment will also be evaluated.
Study design: Double-blind, randomized controlled study.
Patients: GD patients are being selected from the Postgraduate 'Specialist in Oral Medicine' of the Faculty of Dentistry, Complutense University of Madrid.
Allocation: Patients are being randomly assigned to the study group (dental prophylaxis + oral hygiene instructions + use of propolis gel for 4 weeks) or to the placebo group (dental prophylaxis + oral hygiene instructions + use of placebo gel for 4 weeks ). Both the study gel and the placebo are being used for brushing their teeth and for application in areas with GD.
Variables: The severity of the GD will be collected according to the scale of Arduino et al. 2017 and the periodontal variables (plaque index, probing bleeding index and probing depth). Pain during treatment will be recorded using a 10 cm visual analog scale (VAS). The quality of life in relation to oral health will be recorded using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. These variables will be collected on day 0, 2 and 4 weeks after using the study gel or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Nanovitamin E, nanovitamin C and propolis extract gel |
|
| Placebo | Placebo Comparator | Gel without nanovitamin E, nanovitamin C and propolis extract |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dental prophylaxis + oral hygiene instructions | Procedure | Follow up: 2 weeks and 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The severity of the GD will be collected according to the scale of Arduino et al. 2017 | The Scale collects a value for each sextant in vestibular and another value in lingual / palatal (12 in total, six times vestibular and six times lingual / palatal). The criteria for scoring are as follows: (0) no detectable gingival lesions present, (1) only white lesions, (2) mild erythema (<3mm from the gingival margins), (3) one or more blisters or erythema clinically obvious (> 3mm from the gingival margins), (4) erosion or ulcer. When there are different characteristics, the clinician should choose the highest index, so the total score can vary from 0 to 48. Higher results indicate a more serious clinical disease. | Baseline |
| The severity of the GD will be collected according to the scale of Arduino et al. 2017 | The Scale collects a value for each sextant in vestibular and another value in lingual / palatal (12 in total, six times vestibular and six times lingual / palatal). The criteria for scoring are as follows: (0) no detectable gingival lesions present, (1) only white lesions, (2) mild erythema (<3mm from the gingival margins), (3) one or more blisters or erythema clinically obvious (> 3mm from the gingival margins), (4) erosion or ulcer. When there are different characteristics, the clinician should choose the highest index, so the total score can vary from 0 to 48. Higher results indicate a more serious clinical disease. | 2 weeks |
| The severity of the GD will be collected according to the scale of Arduino et al. 2017 | The Scale collects a value for each sextant in vestibular and another value in lingual / palatal (12 in total, six times vestibular and six times lingual / palatal). The criteria for scoring are as follows: (0) no detectable gingival lesions present, (1) only white lesions, (2) mild erythema (<3mm from the gingival margins), (3) one or more blisters or erythema clinically obvious (> 3mm from the gingival margins), (4) erosion or ulcer. When there are different characteristics, the clinician should choose the highest index, so the total score can vary from 0 to 48. Higher results indicate a more serious clinical disease. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Complutense de Madrid | Recruiting | Madrid | 28005 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35900605 | Derived | Gonzalez-Serrano J, Serrano J, Sanz M, Torres J, Hernandez G, Lopez-Pintor RM. Efficacy and safety of a bioadhesive gel containing propolis extract, nanovitamin C and nanovitamin E on desquamative gingivitis: a double-blind, randomized, clinical trial. Clin Oral Investig. 2023 Feb;27(2):879-888. doi: 10.1007/s00784-022-04653-0. Epub 2022 Jul 28. |
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We will try to publish it as a scientific article
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| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D008010 | Lichen Planus |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D017512 | Lichenoid Eruptions |
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| ID | Term |
|---|---|
| D003777 | Dental Prophylaxis |
| ID | Term |
|---|---|
| D010517 | Periodontics |
| D003813 | Dentistry |
| D011313 | Preventive Dentistry |
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| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |