Gingival RecessionNCT04487652
Ubiquinone (Coenzyme Q10) Application After Gingival Recession Coverage
A study testing Gingival recession coverage and with CoQ10 spray application in people with Gingival Recession, run by University of Bern at 1 site in Switzerland.
Trial summary
This randomised double blinded clinical trial has the aim to assess the effect of ubiquinone (Coenzyme Q10) on early wound healing following gingival recession coverage. Coenzyme Q10 (CoQ10) is a critical intermediate of the mitochondrial electron transport chain for the synthesis of adenosine triphosphate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Gingival recession coverage and with CoQ10 spray application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2020to 31 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with single and multiple Miller class I, II and III gingival recessions will be included
- Written informed consent
Who cannot join
- Patients with a history of chronic inflammatory disease
- Patients with severe systemic diseases
- Patients with any sign of clinical infection
- Patients smoking > 5 cigarettes
- Pregnant or lactating women
- Patients < 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ubiquinone (Coenzyme Q10) on Early Wound Healing Following Gingival Recession Coverage: a Pilot Study
This randomised double blinded clinical trial has the aim to assess the effect of ubiquinone (Coenzyme Q10) on early wound healing following gingival recession coverage. Coenzyme Q10 (CoQ10) is a critical intermediate of the mitochondrial electron transport chain for the synthesis of adenosine triphosphate. The biological importance of CoQ10 is related to antioxidant activity, which can scavenge free radicals as well as restore the antioxidant defence system. Both in vitro and animal studies have suggested that CoQ10 acts as anti-inflammatory agent reducing the inflammatory response by inhibiting the translocation of nuclear factor kappa beta into the nucleus.
Gingival recessions particularly in the esthetic area have become a common indication for treatment. The use of subepithelial palatal connective tissue graft (SCTG) in conjunction with either a coronally advanced flap (CAF) or a coronally advanced tunnel are well established techniques for both the treatment of single and multiple gingival recessions.
Interestingly, despite the fact that CoQ10 is widely investigated, virtually no information exists on its effects upon early wound healing of oral tissues. Therefore, the aim of this study is to investigate the effect of CoQ10 on wound healing after gingival recession surgery.
Read the detailed description
Gingival recessions constitute a common problem in the adult population worldwide. In the United States the prevalence of ≥1 mm recession in persons >30 years was 58%, representing over 60 million adults while in a French cohort aged 30-65 years old 84.6% had at least one gingival recession. In two other studies it has been reported that over 90% of adults aged 35 to 50 years and above present with single or multiple gingival recessions. The consequences of gingival recessions can be gingivitis due to suboptimal oral hygiene, tooth mobility and in extreme circumstances tooth loss. Tooth sensitivity, root caries, non-carious cervical lesions and esthetic concerns especially with anteriorly located recessions can be also encountered. With the yearly increase in the number of orthodontic patients a potentially additional burden is expected in the population.
The use of subepithelial palatal connective tissue graft (SCTG) in conjunction with either coronally advanced flap (CAF) or coronally advanced tunnel are well established techniques for the treatment of single and multiple gingival recessions. These techniques have been shown to result in predictable root coverage, higher increase in keratinized tissue and stable long-term outcomes thus being considered today state of the art.
Coenzyme Q10 (CoQ10), referred to as 'ubiquinone', is endogenously synthesised by the mevalonate pathway in the human body and is obtained in much of human diet. CoQ10 is a critical intermediate of the mitochondrial electron transport chain for the synthesis of adenosine triphosphate. The biological importance of CoQ10 is related to antioxidant activity, which can scavenge free radicals as well as restore the antioxidant defence system. Furthermore, in vitro and animal studies have suggested that CoQ10 acts as anti-inflammatory agent reducing the inflammatory response by inhibiting the translocation of nuclear factor kappa beta into the nucleus. Owing to its anti-oxidative and anti-inflammatory capacities CoQ10 is of potential therapeutic value in numerous chronic diseases including periodontitis, rheumatoid arthritis or cardiovascular disease. Moreover, it might exert also beneficial effects on wound healing by reducing inflammation and oxidative stress. A recent clinical trial showed that the serum level of TNF-α was significantly reduced in patients with rheumatoid arthritis who received capsules of CoQ10 (100mg/day) for 8 weeks. However, to date, no published study has investigated the anti-oxidative and anti-inflammation effects of coenzyme Q10 spray on oral wound healing. Thus, the purpose of this clinical study is to examine the early wound healing after coenzyme Q10 spray administration (for 3 weeks) in patients undergoing recession coverage surgery.
For this pilot study 30 patients exhibiting single or multiple gingival recessions (Miller class I-III) will randomly be assigned to the control or test group and will be using a placebo or CoQ10 spray for 3 weeks. The primary endpoint is:
- the progress of wound healing assessed by the early wound healing index EHI previously defined by Wachtel et al. 2003.
The secondary endpoints are:
- the improvement of patients' postoperative comfort see patient questionnaire (VAS scale)
- the percentage of root coverage after 6 months
- Conditions
- Gingival Recession
- Being tested
- Gingival recession coverage, with CoQ10 spray application, with placebo spray application
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival recession coverageOther
The Modified Coronally Advanced Tunnel technique in conjunction with a palatal subepithelial connective tissue graft will be performed.
with CoQ10 spray applicationDrug
After surgical recession coverage a CoQ10 spray will be applied during the early phase of wound healing.
with placebo spray applicationDrug
After surgical recession coverage a placebo spray will be applied during the early phase of wound healing.
| Study group | Role | What they receive |
|---|---|---|
| Placebo spray | Placebo comparator | Spray consists of matrix out of water, phospholipids and glycerine, plus coloration Colour Sunset Yello E 110 to mimic the test spray Receives: Other: Gingival recession coverage; Drug: with placebo spray application |
| CoQ10 spray | Experimental | The CoQ10 spray contains a high quality Kaneka A10 containing CoQ10 trans-isomers which is embedded in a matrix out of water, phospholipids and glycerine. Adana Pharma GmbH is processing the CoQ10 substance into the matrix. One application contains 7 mg CoQ10. Receives: Other: Gingival recession coverage; Drug: with CoQ10 spray application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early wound healing assessed by the early wound healing index by Wachtel
The early wound healing index by Wachtel describes 5 different stages of wound healing from no fibrin coverage until pus formation.
Measured: assessed 2 days after surgery
Early wound healing assessed by the early wound healing index by Wachtel
The early wound healing index by Wachtel describes 5 different stages of wound healing from no fibrin coverage until pus formation.
Measured: assessed 7 days after surgery
Early wound healing assessed by the early wound healing index by Wachtel
The early wound healing index by Wachtel describes 5 different stages of wound healing from no fibrin coverage until pus formation.
Measured: assessed 14 days after surgery
Early wound healing assessed by the early wound healing index by Wachtel
The early wound healing index by Wachtel describes 5 different stages of wound healing from no fibrin coverage until pus formation.
Measured: assessed 21 days after surgery
Secondary outcomes (4)
VAS scale
The patients'postoperative pain level, 1000 mm scale with 0 representing "no pain" and 1000 mm representing "maximal pain"
Measured: 2 days until 21 days postoperatively
Percentage of root coverage
How much expressed in percentage of the baseline recession is covered after 6 months
Measured: 6 months postoperatively
Increase of Keratinized tissue
How much keratinized tissue has been gained
Measured: 6 months postoperatively
Esthetic outcome
Esthetic outcomes will be assessed by the root coverage esthetic score, established by Cairo et al. 2009. Parameters like gingival texture, full coverage, marginal tissue contour, scar tissue are evaluated. The maximal score is 10.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Sep 2020
- Primary completion31 Aug 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by University of BernThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised placebo-controlled, double blinded, mono-centric trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anton Sculean, Prof., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487652
- Sponsor's protocol ID
- 2019-01542
- Other IDs
- 2019
- Status last verified
- Mar 2023
- First submitted
- 22 Jul 2020
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon request the individual participant data will be shared
Publications
Lanzrein C, Guldener K, Imber JC, Katsaros C, Stahli A, Sculean A. Treatment of multiple adjacent recessions with the modified coronally advanced tunnel or laterally closed tunnel in conjunction with cross-linked hyaluronic acid and subepithelial connective tissue graft: a report of 15 cases. Quintessence Int. 2020;51(9):710-719. doi: 10.3290/j.qi.a44808.
PubMed 32577705Guldener K, Lanzrein C, Eliezer M, Katsaros C, Stahli A, Sculean A. Treatment of single mandibular recessions with the modified coronally advanced tunnel or laterally closed tunnel, hyaluronic acid, and subepithelial connective tissue graft: a report of 12 cases. Quintessence Int. 2020;51(6):456-463. doi: 10.3290/j.qi.a44492.
PubMed 32368762Liu HT, Huang YC, Cheng SB, Huang YT, Lin PT. Effects of coenzyme Q10 supplementation on antioxidant capacity and inflammation in hepatocellular carcinoma patients after surgery: a randomized, placebo-controlled trial. Nutr J. 2016 Oct 6;15(1):85. doi: 10.1186/s12937-016-0205-6.
PubMed 27716246Sahebkar A, Simental-Mendia LE, Stefanutti C, Pirro M. Supplementation with coenzyme Q10 reduces plasma lipoprotein(a) concentrations but not other lipid indices: A systematic review and meta-analysis. Pharmacol Res. 2016 Mar;105:198-209. doi: 10.1016/j.phrs.2016.01.030. Epub 2016 Feb 2.
PubMed 26836888Alam MA, Rahman MM. Mitochondrial dysfunction in obesity: potential benefit and mechanism of Co-enzyme Q10 supplementation in metabolic syndrome. J Diabetes Metab Disord. 2014 May 23;13:60. doi: 10.1186/2251-6581-13-60. eCollection 2014.
PubMed 24932457Stahli A, Imber JC, Raptis E, Salvi GE, Eick S, Sculean A. Effect of enamel matrix derivative on wound healing following gingival recession coverage using the modified coronally advanced tunnel and subepithelial connective tissue graft: a randomised, controlled, clinical study. Clin Oral Investig. 2020 Feb;24(2):1043-1051. doi: 10.1007/s00784-019-03008-6. Epub 2019 Jul 9.
PubMed 31290017Stahli A, De Ry SP, Roccuzzo A, Imber JC, Sculean A. Effect of Coenzyme Q10 on early wound healing after recession coverage surgery with the modified coronally advanced tunnel technique and a connective tissue graft: A 6-month, triple-blinded, randomized, placebo-controlled pilot trial. Clin Oral Investig. 2024 Jul 11;28(8):424. doi: 10.1007/s00784-024-05790-4.
PubMed 38990401
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ubiquinone (Coenzyme Q10) on Early Wound Healing Following Gingival Recession Coverage: a Pilot Study
- ClinicalTrials.gov ID
- NCT04487652
- Acronym / sponsor ID
- 2019-01542
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 27 Jul 2020 (actual)
- 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.
This randomised double blinded clinical trial has the aim to assess the effect of ubiquinone (Coenzyme Q10) on early wound healing following gingival recession coverage. Coenzyme Q10 (CoQ10) is a critical intermediate of the mitochondrial electron transport chain for the synthesis of adenosine triphosphate. The biological importance of CoQ10 is related to antioxidant activity, which can scavenge free radicals as well as restore the antioxidant defence system. Both in vitro and animal studies have suggested that CoQ10 acts as anti-inflammatory agent reducing the inflammatory response by inhibiting the translocation of nuclear factor kappa beta into the nucleus.
Gingival recessions particularly in the esthetic area have become a common indication for treatment. The use of subepithelial palatal connective tissue graft (SCTG) in conjunction with either a coronally advanced flap (CAF) or a coronally advanced tunnel are well established techniques for both the treatment of single and multiple gingival recessions.
Interestingly, despite the fact that CoQ10 is widely investigated, virtually no information exists on its effects upon early wound healing of oral tissues. Therefore, the aim of this study is to investigate the effect of CoQ10 on wound healing after gingival recession surgery.
Detailed description
Gingival recessions constitute a common problem in the adult population worldwide. In the United States the prevalence of ≥1 mm recession in persons >30 years was 58%, representing over 60 million adults while in a French cohort aged 30-65 years old 84.6% had at least one gingival recession. In two other studies it has been reported that over 90% of adults aged 35 to 50 years and above present with single or multiple gingival recessions. The consequences of gingival recessions can be gingivitis due to suboptimal oral hygiene, tooth mobility and in extreme circumstances tooth loss. Tooth sensitivity, root caries, non-carious cervical lesions and esthetic concerns especially with anteriorly located recessions can be also encountered. With the yearly increase in the number of orthodontic patients a potentially additional burden is expected in the population.
The use of subepithelial palatal connective tissue graft (SCTG) in conjunction with either coronally advanced flap (CAF) or coronally advanced tunnel are well established techniques for the treatment of single and multiple gingival recessions. These techniques have been shown to result in predictable root coverage, higher increase in keratinized tissue and stable long-term outcomes thus being considered today state of the art.
Coenzyme Q10 (CoQ10), referred to as 'ubiquinone', is endogenously synthesised by the mevalonate pathway in the human body and is obtained in much of human diet. CoQ10 is a critical intermediate of the mitochondrial electron transport chain for the synthesis of adenosine triphosphate. The biological importance of CoQ10 is related to antioxidant activity, which can scavenge free radicals as well as restore the antioxidant defence system. Furthermore, in vitro and animal studies have suggested that CoQ10 acts as anti-inflammatory agent reducing the inflammatory response by inhibiting the translocation of nuclear factor kappa beta into the nucleus. Owing to its anti-oxidative and anti-inflammatory capacities CoQ10 is of potential therapeutic value in numerous chronic diseases including periodontitis, rheumatoid arthritis or cardiovascular disease. Moreover, it might exert also beneficial effects on wound healing by reducing inflammation and oxidative stress. A recent clinical trial showed that the serum level of TNF-α was significantly reduced in patients with rheumatoid arthritis who received capsules of CoQ10 (100mg/day) for 8 weeks. However, to date, no published study has investigated the anti-oxidative and anti-inflammation effects of coenzyme Q10 spray on oral wound healing. Thus, the purpose of this clinical study is to examine the early wound healing after coenzyme Q10 spray administration (for 3 weeks) in patients undergoing recession coverage surgery.
For this pilot study 30 patients exhibiting single or multiple gingival recessions (Miller class I-III) will randomly be assigned to the control or test group and will be using a placebo or CoQ10 spray for 3 weeks. The primary endpoint is:
- the progress of wound healing assessed by the early wound healing index EHI previously defined by Wachtel et al. 2003.
The secondary endpoints are:
- the improvement of patients' postoperative comfort see patient questionnaire (VAS scale)
- the percentage of root coverage after 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised placebo-controlled, double blinded, mono-centric trial
| Arm | Type | Receives |
|---|---|---|
| Placebo spray | Placebo comparator | Other: Gingival recession coverage, Drug: with placebo spray applicationSpray consists of matrix out of water, phospholipids and glycerine, plus coloration Colour Sunset Yello E 110 to mimic the test spray |
| CoQ10 spray | Experimental | Other: Gingival recession coverage, Drug: with CoQ10 spray applicationThe CoQ10 spray contains a high quality Kaneka A10 containing CoQ10 trans-isomers which is embedded in a matrix out of water, phospholipids and glycerine. Adana Pharma GmbH is processing the CoQ10 substance into the matrix. One application contains 7 mg CoQ10. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with single and multiple Miller class I, II and III gingival recessions will be included
- Written informed consent
Key exclusion criteria (6 listed)
- Patients with a history of chronic inflammatory disease
- Patients with severe systemic diseases
- Patients with any sign of clinical infection
- Patients smoking > 5 cigarettes
- Pregnant or lactating women
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 |
|---|---|---|
| Gingival recession coverageThe Modified Coronally Advanced Tunnel technique in conjunction with a palatal subepithelial connective tissue graft will be performed. | Other | CoQ10 spray, Placebo spray |
| with CoQ10 spray applicationAfter surgical recession coverage a CoQ10 spray will be applied during the early phase of wound healing. | Drug | CoQ10 spray |
| with placebo spray applicationAfter surgical recession coverage a placebo spray will be applied during the early phase of wound healing. | Drug | Placebo spray |
Primary outcome
Early wound healing assessed by the early wound healing index by Wachtel
Time frame: assessed 2 days after surgery
The early wound healing index by Wachtel describes 5 different stages of wound healing from no fibrin coverage until pus formation.
Early wound healing assessed by the early wound healing index by Wachtel
Time frame: assessed 7 days after surgery
The early wound healing index by Wachtel describes 5 different stages of wound healing from no fibrin coverage until pus formation.
Early wound healing assessed by the early wound healing index by Wachtel
Time frame: assessed 14 days after surgery
The early wound healing index by Wachtel describes 5 different stages of wound healing from no fibrin coverage until pus formation.
Early wound healing assessed by the early wound healing index by Wachtel
Time frame: assessed 21 days after surgery
The early wound healing index by Wachtel describes 5 different stages of wound healing from no fibrin coverage until pus formation.
4 secondary outcomes
VAS scale
Time frame: 2 days until 21 days postoperatively
Percentage of root coverage
Time frame: 6 months postoperatively
Increase of Keratinized tissue
Time frame: 6 months postoperatively
Esthetic outcome
Time frame: 6 months postoperatively
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 23 Mar 2023.
- Background: PubMed 32577705Lanzrein C, Guldener K, Imber JC, Katsaros C, Stahli A, Sculean A. Treatment of multiple adjacent recessions with the modified coronally advanced tunnel or laterally closed tunnel in conjunction with cross-linked hyaluronic acid and subepithelial connective tissue graft: a report of 15 cases. Quintessence Int. 2020;51(9):710-719. doi: 10.3290/j.qi.a44808.
- Background: PubMed 32368762Guldener K, Lanzrein C, Eliezer M, Katsaros C, Stahli A, Sculean A. Treatment of single mandibular recessions with the modified coronally advanced tunnel or laterally closed tunnel, hyaluronic acid, and subepithelial connective tissue graft: a report of 12 cases. Quintessence Int. 2020;51(6):456-463. doi: 10.3290/j.qi.a44492.
- Background: PubMed 27716246Liu HT, Huang YC, Cheng SB, Huang YT, Lin PT. Effects of coenzyme Q10 supplementation on antioxidant capacity and inflammation in hepatocellular carcinoma patients after surgery: a randomized, placebo-controlled trial. Nutr J. 2016 Oct 6;15(1):85. doi: 10.1186/s12937-016-0205-6.
- Background: PubMed 26836888Sahebkar A, Simental-Mendia LE, Stefanutti C, Pirro M. Supplementation with coenzyme Q10 reduces plasma lipoprotein(a) concentrations but not other lipid indices: A systematic review and meta-analysis. Pharmacol Res. 2016 Mar;105:198-209. doi: 10.1016/j.phrs.2016.01.030. Epub 2016 Feb 2.
- Background: PubMed 24932457Alam MA, Rahman MM. Mitochondrial dysfunction in obesity: potential benefit and mechanism of Co-enzyme Q10 supplementation in metabolic syndrome. J Diabetes Metab Disord. 2014 May 23;13:60. doi: 10.1186/2251-6581-13-60. eCollection 2014.
- Results publication: PubMed 31290017Stahli A, Imber JC, Raptis E, Salvi GE, Eick S, Sculean A. Effect of enamel matrix derivative on wound healing following gingival recession coverage using the modified coronally advanced tunnel and subepithelial connective tissue graft: a randomised, controlled, clinical study. Clin Oral Investig. 2020 Feb;24(2):1043-1051. doi: 10.1007/s00784-019-03008-6. Epub 2019 Jul 9.
- Derived from this study: PubMed 38990401Stahli A, De Ry SP, Roccuzzo A, Imber JC, Sculean A. Effect of Coenzyme Q10 on early wound healing after recession coverage surgery with the modified coronally advanced tunnel technique and a connective tissue graft: A 6-month, triple-blinded, randomized, placebo-controlled pilot trial. Clin Oral Investig. 2024 Jul 11;28(8):424. doi: 10.1007/s00784-024-05790-4.
- Individual participant dataSharing planned: No. Upon request the individual participant data will be shared
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Gingival Recession
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.
Anton Sculean, Prof. principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gingival recession coverage and with CoQ10 spray application in people with Gingival Recession, run by University of Bern at 1 site in Switzerland.
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 6 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 23 Mar 2023. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Early wound healing assessed by the early wound healing index by Wachtel (time frame: assessed 2 days after surgery). The study lists 4 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 NCT04487652, which also lists 7 linked publications.
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 23 Mar 2023.