Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04487652
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2020-07-22
Brief Title:
Ubiquinone Coenzyme Q10 Application After Gingival Recession Coverage
Sponsor:
University of Bern
Organization:
University of Bern
Study Overview
Official Title:
Effect of Ubiquinone Coenzyme Q10 on Early Wound Healing Following Gingival Recession Coverage a Pilot Study
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 846 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 100mgday 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
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 100mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None