Gingival Recession Coverage With and Without Emdogain

NCT02230787 | Completed Phase 4

• 1 other identifier: 186/13
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Enamel matrix proteins have been shown to play a crucial role during tooth development and its supporting tissues. This is used in periodontal surgery where regeneration of lost tissues around the teeth is intended. Emdogain, a product of Straumann Institute contains these matrix proteins and has been successfully used in regenerative periodontal surgery for more than 16 years. The treatment of gum recession is a common requirement, more and more patients are seeking treatment at the investigators' clinic due to aesthetic concern, root sensitivity and difficulties in performing adequate oral hygiene. The standard treatment comprises the transplantation of a piece of connective tissue from the palate to the denuded root surface. In many cases Emdogain is additionally applied to enhance healing. So far the effect of Emdogain on the early wound healing process after surgical root coverage has not been investigated. The purpose of the investigators' study is to compare early wound healing parameters between treatment with and without Emdogain. For this study 40 patients undergoing root coverage surgery at the investigators' department will be included. Early wound healing features between the two groups will be described and compared. Furthermore, inflammatory markers typical for early healing will be evaluated together with patients'subjective postoperative comfort. Finally, outcomes 6 months after the treatment will be assessed. The investigators' hypothesis is that Emdogain treatment enhances wound healing and decreases post-operative complication rates.

Conditions

Gingival Recession; Emdogain

Keywords

Pilot study; randomized clinical trial; periodontal disease; gingival recession; Emdogain; connective tissue; wound healing; inflammation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in wound healing

  Progress in wound healing assessed by the "early wound healing index (EHI)" previously defined by Wachtel et al.

  2, 7 and 14 days after surgery

Secondary Outcomes (3)

• Levels of post-procedural inflammatory markers

  2 and 7 days after surgery

• Improvement of patients' post-operative comfort

  2 days to 2 weeks after surgery

• Root coverage

  6 months after surgery

Study Arms (2)

Recession coverage without Emdogain

ACTIVE COMPARATOR

Device: Recession coverage without Emdogain

Recession coverage with Emdogain

EXPERIMENTAL

Device: Recession coverage with Emdogain

Interventions

Recession coverage without Emdogain DEVICE

In the control group subjects the recession coverage surgery will be performed without Emdogain.

Recession coverage without Emdogain

Recession coverage with Emdogain DEVICE

In the test group subjects the recession coverage surgery will be performed with Emdogain.

Recession coverage with Emdogain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gingival recession Miller class I and II
• Written informed consent

You may not qualify if:

• Patients with a history of a chronic infectious or inflammatory diseases (i.e. rheumatoid arthritis, systemic lupus erythematodes, Crohn's disease, or HIV-, HCV-infection etc.
• Patients with any clinical signs of an acute infection
• Patients with renal failure (GFR \< 30ml/min)
• Smoking \> 5 cigarettes per day
• Patients \< 18 years of age

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Department of Periodontology, University of Bern

Bern, 3010, Switzerland

Location

Related Publications (8)

• Grandin HM, Gemperli AC, Dard M. Enamel matrix derivative: a review of cellular effects in vitro and a model of molecular arrangement and functioning. Tissue Eng Part B Rev. 2012 Jun;18(3):181-202. doi: 10.1089/ten.TEB.2011.0365. Epub 2011 Dec 28.

  PMID: 22070552 BACKGROUND

• Spahr A, Haegewald S, Tsoulfidou F, Rompola E, Heijl L, Bernimoulin JP, Ring C, Sander S, Haller B. Coverage of Miller class I and II recession defects using enamel matrix proteins versus coronally advanced flap technique: a 2-year report. J Periodontol. 2005 Nov;76(11):1871-80. doi: 10.1902/jop.2005.76.11.1871.

  PMID: 16274306 BACKGROUND

• Wachtel H, Schenk G, Bohm S, Weng D, Zuhr O, Hurzeler MB. Microsurgical access flap and enamel matrix derivative for the treatment of periodontal intrabony defects: a controlled clinical study. J Clin Periodontol. 2003 Jun;30(6):496-504. doi: 10.1034/j.1600-051x.2003.00013.x.

  PMID: 12795787 BACKGROUND

• Cairo F, Pagliaro U, Nieri M. Treatment of gingival recession with coronally advanced flap procedures: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):136-62. doi: 10.1111/j.1600-051X.2008.01267.x.

  PMID: 18724847 BACKGROUND

• Henriques PS, Pelegrine AA, Nogueira AA, Borghi MM. Application of subepithelial connective tissue graft with or without enamel matrix derivative for root coverage: a split-mouth randomized study. J Oral Sci. 2010 Sep;52(3):463-71. doi: 10.2334/josnusd.52.463.

  PMID: 20881341 RESULT

• Cueva MA, Boltchi FE, Hallmon WW, Nunn ME, Rivera-Hidalgo F, Rees T. A comparative study of coronally advanced flaps with and without the addition of enamel matrix derivative in the treatment of marginal tissue recession. J Periodontol. 2004 Jul;75(7):949-56. doi: 10.1902/jop.2004.75.7.949.

  PMID: 15341352 RESULT

• Aroca S, Molnar B, Windisch P, Gera I, Salvi GE, Nikolidakis D, Sculean A. Treatment of multiple adjacent Miller class I and II gingival recessions with a Modified Coronally Advanced Tunnel (MCAT) technique and a collagen matrix or palatal connective tissue graft: a randomized, controlled clinical trial. J Clin Periodontol. 2013 Jul;40(7):713-20. doi: 10.1111/jcpe.12112. Epub 2013 Apr 30.

  PMID: 23627374 RESULT

• Rasperini G, Roccuzzo M, Francetti L, Acunzo R, Consonni D, Silvestri M. Subepithelial connective tissue graft for treatment of gingival recessions with and without enamel matrix derivative: a multicenter, randomized controlled clinical trial. Int J Periodontics Restorative Dent. 2011 Apr;31(2):133-9.

  PMID: 21491012 RESULT

MeSH Terms

Conditions

Gingival Recession; Periodontal Diseases; Inflammation

Condition Hierarchy (Ancestors)

Gingival Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anton Sculean, Prof. Dr. med. dent.

  Department of Periodontology, University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: September 3, 2014
• Study Start: August 1, 2014
• Primary Completion: April 22, 2016
• Study Completion: February 14, 2017
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

CH (1)