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Effects of Topical Hyaluronic Acid Gel on Postoperative Pain and Wound Healing

Primary Purpose

Palatal Wound

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hyaluronic acid
Control
Sponsored by
Colgate Palmolive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Palatal Wound focused on measuring Topical hyaluronic acid, Postoperative pain, Wound healing, Epithelialized, Palate, supportive care, Treatment, Prevention

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Faveri AcademyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I

Group II

Arm Description

A gel containing Hyaluronic acid in combination with a hemostatic sponge

A hemostatic sponge alone

Outcomes

Primary Outcome Measures

Wound healing area
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
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
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
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
March 22, 2023
Last Updated
August 28, 2023
Sponsor
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT05821725
Brief Title
Effects of Topical Hyaluronic Acid Gel on Postoperative Pain and Wound Healing
Official Title
Clinical Study to Evaluate the Effects of a Topical Hyaluronic Acid (HA) Gel on Postoperative Pain and Wound Healing at Palatal Donor Sites in Subjects Undergoing Mucogingival Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colgate Palmolive

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palatal Wound
Keywords
Topical hyaluronic acid, Postoperative pain, Wound healing, Epithelialized, Palate, supportive care, Treatment, Prevention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
A gel containing Hyaluronic acid in combination with a hemostatic sponge
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
A hemostatic sponge alone
Intervention Type
Device
Intervention Name(s)
Hyaluronic acid
Intervention Description
Hyaluronic acid and hemostatic sponge
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
Hemostatic sponge
Primary Outcome Measure Information:
Title
Wound healing area
Description
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
Time Frame
Baseline
Title
Wound healing area
Description
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
Time Frame
3 days after surgery
Title
Wound healing area
Description
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
Time Frame
7 days after surgery
Title
Wound healing area
Description
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
Time Frame
14 days after surgery
Title
Wound healing area
Description
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
Time Frame
21 days after surgery
Title
Wound healing area
Description
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
Time Frame
42 days after surgery
Secondary Outcome Measure Information:
Title
Pain assessment
Description
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.
Time Frame
Baseline
Title
Pain assessment
Description
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.
Time Frame
3 days after surgery
Title
Pain assessment
Description
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.
Time Frame
7 days after surgery
Title
Pain assessment
Description
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.
Time Frame
14 days after surgery
Title
Pain assessment
Description
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.
Time Frame
21 days after surgery
Title
Pain assessment
Description
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.
Time Frame
42 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo Faveri, DDS, PhD
Phone
551198644-9962
Email
mdfaveri@uol.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Faveri, DDS, PhD
Organizational Affiliation
Faveri Academy
Official's Role
Study Director
Facility Information:
Facility Name
Faveri Academy
City
Guarulhos
State/Province
São Paulo
ZIP/Postal Code
04081-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelo Faveri, DDS, PhD
Phone
551198644-9962
Email
marcelo@faveriacademy.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Topical Hyaluronic Acid Gel on Postoperative Pain and Wound Healing

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