Ubiquinone (Coenzyme Q10) Application After Gingival Recession Coverage

NCT04487652 | Completed

• 1 other identifier: 2019-01542
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  assessed 21 days after surgery

Secondary Outcomes (4)

• VAS scale

  2 days until 21 days postoperatively

• Percentage of root coverage

  6 months postoperatively

• Increase of Keratinized tissue

  6 months postoperatively

• Esthetic outcome

  6 months postoperatively

Study Arms (2)

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

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.

Other: Gingival recession coverage; Drug: with CoQ10 spray application

Interventions

Gingival recession coverage OTHER

The Modified Coronally Advanced Tunnel technique in conjunction with a palatal subepithelial connective tissue graft will be performed.

CoQ10 spray; Placebo spray

with CoQ10 spray application DRUG

After surgical recession coverage a CoQ10 spray will be applied during the early phase of wound healing.

CoQ10 spray

with placebo spray application DRUG

After surgical recession coverage a placebo spray will be applied during the early phase of wound healing.

Placebo spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with single and multiple Miller class I, II and III gingival recessions will be included
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Department of Periodontology

Bern, 3010, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 32577705 BACKGROUND

• 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.

  PMID: 32368762 BACKGROUND

• 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.

  PMID: 27716246 BACKGROUND

• 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.

  PMID: 26836888 BACKGROUND

• 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.

  PMID: 24932457 BACKGROUND

• 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.

  PMID: 31290017 RESULT

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Anton Sculean, Prof.

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised placebo-controlled, double blinded, mono-centric trial

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: September 1, 2020
• Primary Completion: August 31, 2022
• Study Completion: January 31, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)