Ubiquinone (Coenzyme Q10) Application After Gingival Recession Coverage
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Gingival recession coverage
with CoQ10 spray application
with placebo spray application
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession
Eligibility Criteria
Inclusion Criteria:
- Patients with single and multiple Miller class I, II and III gingival recessions will be included
- Written informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Department of Periodontology
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo spray
CoQ10 spray
Arm Description
Spray consists of matrix out of water, phospholipids and glycerine, plus coloration Colour Sunset Yello E 110 to mimic the test spray
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
VAS scale
The patients'postoperative pain level, 1000 mm scale with 0 representing "no pain" and 1000 mm representing "maximal pain"
Percentage of root coverage
How much expressed in percentage of the baseline recession is covered after 6 months
Increase of Keratinized tissue
How much keratinized tissue has been gained
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04487652
Brief Title
Ubiquinone (Coenzyme Q10) Application After Gingival Recession Coverage
Official Title
Effect of Ubiquinone (Coenzyme Q10) on Early Wound Healing Following Gingival Recession Coverage: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised placebo-controlled, double blinded, mono-centric trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo spray
Arm Type
Placebo Comparator
Arm Description
Spray consists of matrix out of water, phospholipids and glycerine, plus coloration Colour Sunset Yello E 110 to mimic the test spray
Arm Title
CoQ10 spray
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Gingival recession coverage
Intervention Description
The Modified Coronally Advanced Tunnel technique in conjunction with a palatal subepithelial connective tissue graft will be performed.
Intervention Type
Drug
Intervention Name(s)
with CoQ10 spray application
Intervention Description
After surgical recession coverage a CoQ10 spray will be applied during the early phase of wound healing.
Intervention Type
Drug
Intervention Name(s)
with placebo spray application
Intervention Description
After surgical recession coverage a placebo spray will be applied during the early phase of wound healing.
Primary Outcome Measure Information:
Title
Early wound healing assessed by the early wound healing index by Wachtel
Description
The early wound healing index by Wachtel describes 5 different stages of wound healing from no fibrin coverage until pus formation.
Time Frame
assessed 2 days after surgery
Title
Early wound healing assessed by the early wound healing index by Wachtel
Description
The early wound healing index by Wachtel describes 5 different stages of wound healing from no fibrin coverage until pus formation.
Time Frame
assessed 7 days after surgery
Title
Early wound healing assessed by the early wound healing index by Wachtel
Description
The early wound healing index by Wachtel describes 5 different stages of wound healing from no fibrin coverage until pus formation.
Time Frame
assessed 14 days after surgery
Title
Early wound healing assessed by the early wound healing index by Wachtel
Description
The early wound healing index by Wachtel describes 5 different stages of wound healing from no fibrin coverage until pus formation.
Time Frame
assessed 21 days after surgery
Secondary Outcome Measure Information:
Title
VAS scale
Description
The patients'postoperative pain level, 1000 mm scale with 0 representing "no pain" and 1000 mm representing "maximal pain"
Time Frame
2 days until 21 days postoperatively
Title
Percentage of root coverage
Description
How much expressed in percentage of the baseline recession is covered after 6 months
Time Frame
6 months postoperatively
Title
Increase of Keratinized tissue
Description
How much keratinized tissue has been gained
Time Frame
6 months postoperatively
Title
Esthetic outcome
Description
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.
Time Frame
6 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with single and multiple Miller class I, II and III gingival recessions will be included
Written informed consent
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anton Sculean, Prof.
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Periodontology
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Upon request the individual participant data will be shared
Citations:
PubMed Identifier
32577705
Citation
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.
Results Reference
background
PubMed Identifier
32368762
Citation
Guldener 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.
Results Reference
background
PubMed Identifier
27716246
Citation
Liu 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.
Results Reference
background
PubMed Identifier
26836888
Citation
Sahebkar 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.
Results Reference
background
PubMed Identifier
24932457
Citation
Alam 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 Reference
background
PubMed Identifier
31290017
Citation
Stahli 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.
Results Reference
result
Learn more about this trial
Ubiquinone (Coenzyme Q10) Application After Gingival Recession Coverage
We'll reach out to this number within 24 hrs