Effects of Topical Hyaluronic Acid Gel on Postoperative Pain and Wound Healing
Study Details
Study Description
Brief Summary
This clinical study aims to investigate the impact of a topical hyaluronic acid (HA) gel on postoperative pain and wound healing at palatal donor sites in patients undergoing mucogingival procedures involving a de-epithelialized gingival graft (DGG) from the palate. The study design is a Phase III, randomized, double-blind, parallel-group, clinical trial, conducted in a single center, with 30 subjects aged 18-70 years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group I A gel containing Hyaluronic acid in combination with a hemostatic sponge |
Device: Hyaluronic acid
Hyaluronic acid and hemostatic sponge
|
| Active Comparator: Group II A hemostatic sponge alone |
Device: Control
Hemostatic sponge
|
Outcome Measures
Primary Outcome Measures
- Wound healing area [Baseline]
Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter
- Wound healing area [3 days after surgery]
Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter
- Wound healing area [7 days after surgery]
Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter
- Wound healing area [14 days after surgery]
Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter
- Wound healing area [21 days after surgery]
Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter
- Wound healing area [42 days after surgery]
Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter
Secondary Outcome Measures
- Pain assessment [Baseline]
Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating "No pain" and on the other end the verbal anchor of "The most intense pain that I ever felt". The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded.
- Pain assessment [3 days after surgery]
Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating "No pain" and on the other end the verbal anchor of "The most intense pain that I ever felt". The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded.
- Pain assessment [7 days after surgery]
Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating "No pain" and on the other end the verbal anchor of "The most intense pain that I ever felt". The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded.
- Pain assessment [14 days after surgery]
Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating "No pain" and on the other end the verbal anchor of "The most intense pain that I ever felt". The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded.
- Pain assessment [21 days after surgery]
Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating "No pain" and on the other end the verbal anchor of "The most intense pain that I ever felt". The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded.
- Pain assessment [42 days after surgery]
Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating "No pain" and on the other end the verbal anchor of "The most intense pain that I ever felt". The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males and females, between 18-70 years of age
-
Informed Consent Form signed and availability for the duration of the study
-
Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study
-
Clinical indication for mucogingival surgery that requires a de-epithelialized gingival graft (DGG) from the palate
-
Willingness to provide information related to their medical history
-
Minimum of 10 uncrowned permanent natural teeth (excluding third molars)
-
Normal salivary flow
Exclusion Criteria:
-
Oral pathology, chronic disease, or a history of allergy to testing products
-
Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study
-
Subject participating in any other clinical study
-
Subject pregnant or breastfeeding
-
Subject allergic to oral care products, personal care consumer products, or their ingredients
-
Extended use of antibiotics or therapeutic mouthwash any time during the three months prior to entry into the study
-
A medical history reporting that the subject has a current systemic or autoimmune disease, such as diabetes, lupus, etc
-
Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faveri Academy | Guarulhos | São Paulo | Brazil | 04081-010 |
Sponsors and Collaborators
- Colgate Palmolive
Investigators
- Study Director: Marcelo Faveri, DDS, PhD, Faveri Academy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRO-2022-09-WH-BZ-ZM