An interventional study of Gingival recession coverage and with CoQ10 spray application in Gingival Recession, sponsored by University of Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by University of Bern · Not applicable, Interventional, and Treatment
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.
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 secondary endpoints are:
402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's enrollment of 30 is close to the median of 30 across 368 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →University of Bern is the lead sponsor of 207 studies on the registry; 47 are open to participants now.
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Exclusion Criteria:
Spray consists of matrix out of water, phospholipids and glycerine, plus coloration Colour Sunset Yello E 110 to mimic the test spray
Other: Gingival recession coverage · Drug: with placebo spray application
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.
Other: Gingival recession coverage · Drug: with CoQ10 spray application
The Modified Coronally Advanced Tunnel technique in conjunction with a palatal subepithelial connective tissue graft will be performed.
After surgical recession coverage a CoQ10 spray will be applied during the early phase of wound healing.
After surgical recession coverage a placebo spray will be applied during the early phase of wound healing.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: assessed 21 days after surgery
VAS scale
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
Percentage of root coverage
How much expressed in percentage of the baseline recession is covered after 6 months
Time frame: 6 months postoperatively
Increase of Keratinized tissue
How much keratinized tissue has been gained
Time frame: 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.
Time frame: 6 months postoperatively
Plan to share: No — Upon request the individual participant data will be shared
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University of Bern