Wound Healing ComplicationPhase 4NCT02534415
Effect of Topically-Applied Hyaluronic-Acid on Palatal Epithelial Wound Closure
A Phase 4 study testing Periodontal dressing material, 0.2% Hyaluronic acid gel and 0.8% Hyaluronic acid gel in people with Wound Healing Complication, run by Marmara University.
Trial summary
Aim of the study is to assess the therapeutic effects of topical hyaluronic-acid use on secondary wound healing of the free gingival graft donor site. The hypothesis of this study is that topical hyaluronic-acid gel has positive effects on secondary wound healing of free gingival graft donor site by reducing pain… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Healing Complication
- What is being tested?
- Periodontal dressing material, 0.2% Hyaluronic acid gel and 0.8% Hyaluronic acid gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Aug 2015
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good general health
- No periodontal surgical treatment in the previous 6 months on the involved sites
Who cannot join
- Smoking
- Patients with a pregnancy or lactation period
- Self-reported history of antibiotic medication within three months
- Absence of tooth in the area of donor site
About this study
Aim of the study is to assess the therapeutic effects of topical hyaluronic-acid use on secondary wound healing of the free gingival graft donor site. The hypothesis of this study is that topical hyaluronic-acid gel has positive effects on secondary wound healing of free gingival graft donor site by reducing pain, burning sensation, and accelerating the healing.
Read the detailed description
The objective of the randomized, single blind, controlled and parallel clinical trial was to assess therapeutic effects of topical hyaluronic-acid on secondary wound healing of free gingival graft donor site.
Primary outcome variables that pain and burning sensation changes were assessed at 3, 7, 14, 21 days after surgery by the examiner. Pain and burning sensation were assessed by patients using the VAS, score 0 indicate no pain or burning sensation, score 10 indicate severe pain or burning sensation. Secondary outcome variables included color match, consistency and epithelization of the wound area. These parameters were assessed by the same examiner at 3, 7, 14, 21 and 42 days after surgery. Color of the palatal mucosa was assessed by comparing it to that of the adjacent and opposite site using the VAS. Score 0 indicate no color match and score 10 indicate very good color match. Consistency of the palatal mucosa was assessed with a blunt instrumentation and scored as soft or firm. Epithelialization was scored clinically as none, partial or complete.
Sample size has been estimated in 12 subjects per treatment groups. Random allocation of the treatment sites to test and control groups will be performed using a computerized selection of random numbers for allocation of the study groups.
Clinical images obtained at baseline, 3, 7, 14, 21 and 42 days after surgery from each treatment site.
- Conditions
- Wound Healing Complication
- Being tested
- Periodontal dressing material, 0.2% Hyaluronic acid gel, 0.8% Hyaluronic acid gel
- Keywords
- Antiinflammatory, Gingiva, Hyaluronic acid, Palate, Transplants, Wound healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal dressing materialDrug
Also called Peripac®
Procedure:Palatal wound area was covered with periodontal dressing material at baseline and 3rd day
0.2% Hyaluronic acid gelDrug
Also called Gengigel
0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
0.8% Hyaluronic acid gelDrug
Also called Gengigel
0.8% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
| Study group | Role | What they receive |
|---|---|---|
| Periodontal dressing material | Active comparator | Palatal wound area was covered with periodontal dressing material at baseline and 3rd day Receives: Drug: Periodontal dressing material |
| 0.2% Hyaluronic acid gel | Experimental | 0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day Receives: Drug: 0.2% Hyaluronic acid gel |
| 0.8% Hyaluronic acid gel | Experimental | 0.8% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day Receives: Drug: 0.8% Hyaluronic acid gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Using a visual analog scale (0: No pain, 10: Severe pain)
Measured: 21 days
Secondary outcomes (4)
Color match
Using a visual analog scale (0: No color match, 10: Good color match) (Adjacent and opposite site)
Measured: 42 days
Consistency
Soft/firm
Measured: 42 days
Epithelialisation
None/partial/complete
Measured: 42 days
Burning Sensation
Using a visual analog scale (0: No burning sensation, 10: Severe burning sensation)
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startAug 2013
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Healing ComplicationStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bahar Kuru, Prof. Dr., Study director, Marmara University, Faculty of Denistry, Department of PeriodontologyBaşak Doğan, Prof. Dr., Study chair, Marmara University, Faculty of Denistry, Department of PeriodontologyHatice Selin Yıldırım, Dr., Principal investigator, Marmara University, Faculty of Denistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534415
- Sponsor's protocol ID
- YU-351
- Status last verified
- Aug 2015
- First submitted
- 17 Aug 2015
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topically-Applied Hyaluronic-Acid on Palatal Epithelial Wound Closure
- ClinicalTrials.gov ID
- NCT02534415
- Acronym / sponsor ID
- YU-351
- Conditions
- Wound Healing Complication
- Keywords
- Antiinflammatory, Gingiva, Hyaluronic acid, Palate, Transplants, Wound healing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study is to assess the therapeutic effects of topical hyaluronic-acid use on secondary wound healing of the free gingival graft donor site. The hypothesis of this study is that topical hyaluronic-acid gel has positive effects on secondary wound healing of free gingival graft donor site by reducing pain, burning sensation, and accelerating the healing.
Detailed description
The objective of the randomized, single blind, controlled and parallel clinical trial was to assess therapeutic effects of topical hyaluronic-acid on secondary wound healing of free gingival graft donor site.
Primary outcome variables that pain and burning sensation changes were assessed at 3, 7, 14, 21 days after surgery by the examiner. Pain and burning sensation were assessed by patients using the VAS, score 0 indicate no pain or burning sensation, score 10 indicate severe pain or burning sensation. Secondary outcome variables included color match, consistency and epithelization of the wound area. These parameters were assessed by the same examiner at 3, 7, 14, 21 and 42 days after surgery. Color of the palatal mucosa was assessed by comparing it to that of the adjacent and opposite site using the VAS. Score 0 indicate no color match and score 10 indicate very good color match. Consistency of the palatal mucosa was assessed with a blunt instrumentation and scored as soft or firm. Epithelialization was scored clinically as none, partial or complete.
Sample size has been estimated in 12 subjects per treatment groups. Random allocation of the treatment sites to test and control groups will be performed using a computerized selection of random numbers for allocation of the study groups.
Clinical images obtained at baseline, 3, 7, 14, 21 and 42 days after surgery from each treatment site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontal dressing material | Active comparator | Drug: Periodontal dressing materialPalatal wound area was covered with periodontal dressing material at baseline and 3rd day |
| 0.2% Hyaluronic acid gel | Experimental | Drug: 0.2% Hyaluronic acid gel0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day |
| 0.8% Hyaluronic acid gel | Experimental | Drug: 0.8% Hyaluronic acid gel0.8% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Good general health
- No periodontal surgical treatment in the previous 6 months on the involved sites
Key exclusion criteria (4 listed)
- Smoking
- Patients with a pregnancy or lactation period
- Self-reported history of antibiotic medication within three months
- Absence of tooth in the area of donor site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal dressing materialAlso: Peripac®Procedure:Palatal wound area was covered with periodontal dressing material at baseline and 3rd day | Drug | Periodontal dressing material |
| 0.2% Hyaluronic acid gelAlso: Gengigel0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day | Drug | 0.2% Hyaluronic acid gel |
| 0.8% Hyaluronic acid gelAlso: Gengigel0.8% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day | Drug | 0.8% Hyaluronic acid gel |
Primary outcome
Pain
Time frame: 21 days
Using a visual analog scale (0: No pain, 10: Severe pain)
4 secondary outcomes
Color match
Time frame: 42 days
Consistency
Time frame: 42 days
Epithelialisation
Time frame: 42 days
Burning Sensation
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bahar Kuru, Prof. Dr. study director
Marmara University, Faculty of Denistry, Department of Periodontology
Başak Doğan, Prof. Dr. study chair
Marmara University, Faculty of Denistry, Department of Periodontology
Hatice Selin Yıldırım, Dr. principal investigator
Marmara University, Faculty of Denistry, Department of Periodontology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Periodontal dressing material, 0.2% Hyaluronic acid gel and 0.8% Hyaluronic acid gel in people with Wound Healing Complication, run by Marmara University.
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 2 inclusion and 4 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 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2015.