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Palatal WoundNCT05821725

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

A study testing Hyaluronic acid in people with Palatal Wound, run by Colgate Palmolive at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Palatal Wound
What is being tested?
Hyaluronic acid
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBrazil
Study dates
15 Jul 2023to 21 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Faveri Academy

    Guarulhos, São Paulo, 04081-010

Other trials in Brazil

About this study

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

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.

Conditions
Palatal Wound
Being tested
Hyaluronic acid, Control
Keywords
Topical hyaluronic acid, Postoperative pain, Wound healing, Epithelialized, Palate, supportive care, Treatment, Prevention
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyaluronic acidDevice

    Hyaluronic acid and hemostatic sponge

  • ControlDevice

    Hemostatic sponge

Study groups in NCT05821725
Study groupRoleWhat they receive
Group IExperimentalA gel containing Hyaluronic acid in combination with a hemostatic sponge
Receives: Device: Hyaluronic acid
Group IIActive comparatorA hemostatic sponge alone
Receives: Device: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline

  2. 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

    Measured: 3 days after surgery

  3. 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

    Measured: 7 days after surgery

  4. 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

    Measured: 14 days after surgery

  5. 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

    Measured: 21 days after surgery

  6. 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

    Measured: 42 days after surgery

Secondary outcomes (6)

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: 3 days after surgery

  3. 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.

    Measured: 7 days after surgery

  4. 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.

    Measured: 14 days after surgery

  5. 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.

    Measured: 21 days after surgery

  6. 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.

    Measured: 42 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start15 Jul 2023
  3. Primary completion21 Nov 2023
  4. Study completion21 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05821725
Sponsor's protocol ID
CRO-2022-09-WH-BZ-ZM
Status last verified
Aug 2023
First submitted
22 Mar 2023
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Hyaluronic acid in people with Palatal Wound, run by Colgate Palmolive at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wound healing area (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05821725.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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