Flapless Application of Enamel Matrix Derivative in Class II Mandibular Furcation Defects

NCT05541614 | Unknown

• 1 other identifier: 155/14-03-2022
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Patients diagnosed with stage III or IV periodontitis that exhibit mandibular first or second molars with increased periodontal probing depth (PPD \> 4 mm) and class II buccal mandibular furcation defects (horizontal probing depth of \>= 3 mm ) will be recruited. This study will be a non-inferiority, prospective, randomized, double-blind controlled clinical trial with a parallel design. Patient will be recruited from the clinics of the School of Dentistry at the Aristotle University of Thessaloniki and private dental practices in Thessaloniki, Greece. Initially, non-surgical periodontal treatment will be performed through scaling and root planning in combination with oral hygiene instructions and motivation. The re-evaluation will be performed 4-6 weeks following the treatment and the patients who meet the inclusion criteria will be included in the study. Patients will be randomly allocated at a 1:1 ratio to either subgingival debridement and flapless application of EMD (test group) into the affected furcation defect or to periodontal surgery in combination with EMD application (control group). Periodontal and radiographic parameters, patient reported outcomes, oral cavity measurements and gingival crevicular fluid will be collected before as well as up to 9 months following the treatment.

Conditions

Periodontal Diseases; Periodontal Disease, AVDC Stage 3; Periodontal Disease, AVDC Stage 4; Furcation Defects

Keywords

Periodontal disease; Enamel Matrix Derivative; EMD; Flapless; MINST; Periodontal treatment; Furcation defect

Outcome Measures

Primary Outcomes (1)

• Periodontal probing pocket depth (PPD) change

  Changes in pocket probing depth will be measured using a periodontal probe. The depth of the sulcus will be assessed by gently inserting a graduated periodontal probe until resistance is encountered at the base of the sulcus. The depth from the free gingival margin to the base of the sulcus is measured in millimeters and represents PPD.

  9 months after treatment

Secondary Outcomes (9)

• Horizontal and vertical furcation involvement change.

  9 months after treatment

• Periodontal clinical attachment level (CAL) change.

  9 months after treatment

• Bleeding on Probing (BOP) change

  9 months after treatment

• Gingival recession (REC) change

  9 months after treatment

• Furcation involvement grade change

  9 months after treatment

Study Arms (2)

Subgingival debridement + Flapless Enamel Matrix Derivative

EXPERIMENTAL

Subgingival debridement following a minimally-invasive non-surgical treatment (MINST) approach with flapless application of EMD Root instrumentation under local anesthesia using mini hand instruments (mini curettes) and ultrasonic instruments with fine tips in the furcation area of mandibular first or second molars with class II buccal furcation defects. EDTA gel will be applied for 2 minutes on the affected root surfaces, followed by rinsing with saline and drying prior to the application of Emdogain® FL. Emdogain® FL has been shown to enhance the early healing of periodontal soft tissue wounds resulting from the instrumentation of periodontal pockets.

Other: Emdogain® FL (flapless Emdogain®) - Enamel Matrix Derivative

Periodontal surgery + Enamel Matrix Derivative

ACTIVE COMPARATOR

Periodontal surgery following a minimally-invasive surgical treatment (MIST) protocol with application of EMD Following local anesthesia, minimal flap elevation on the buccal aspect of first or second molars associated with a grade II furcation defect will be performed.Removal of granulation tissues and root instrumentation with mini hand instruments (mini curettes) and ultrasonic instruments with fine tips in the furcation area will then be carried out. EDTA gel will be applied for 2 minutes on the affected root surfaces, followed by rinsing with saline and drying prior to the application of Emdogain®. Then, the surgical flaps will be positioned and sutured in order to completely cover the defects.

Other: Emdogain® - Enamel Matrix Derivative

Interventions

Emdogain® FL (flapless Emdogain®) - Enamel Matrix Derivative OTHER

Emdogain® FL has been shown to enhance the early healing of periodontal soft tissue wounds resulting from the instrumentation of periodontal pockets.

Subgingival debridement + Flapless Enamel Matrix Derivative

Emdogain® - Enamel Matrix Derivative OTHER

Enamel matrix derivative (EMD) has been widely used in the surgical treatment of periodontal disease and in furcation defects.

Periodontal surgery + Enamel Matrix Derivative

Eligibility Criteria

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

You may qualify if:

• Individuals of at least 18 years of age with a diagnosis of stage III or IV periodontitis.
• Have at least one class II furcation defect with PPD \>4 mm and horizontal probing depth of \>= 3 mm in a mandibular first or second molar.
• Teeth have to be vital or properly treated endodontically.
• Gingival recession ≤ 2mm on furcation site
• Proper oral hygiene: full-mouth plaque score (FMPS) ≤20%.
• Systemically healthy (absence of systemic conditions such as diabetes mellitus that can affect the treatment outcome of periodontal therapy)
• Ability to understand the study procedures and comply with them through the length of the study.
• Given written informed consent form for participation in the study.

You may not qualify if:

• Pregnant or lactating female (self-reported).
• Current acute infection.
• Non-surgical periodontal treatment within the last 6 months or/and surgical periodontal treatment the last 12 months before the initial pre-treatment.
• Need for antibiotic premedication.
• Antibiotic treatment in the previous 3 months.
• Allergy to any materials or medications that could be used during or after the procedure.
• Teeth having an improper endodontic therapy with clinical signs of infection or subgingival restorations.
• Tooth mobility of 2nd and 3rd degree.
• History of radiation therapy in the head and neck region.
• Chronic use of medications that may alter the response of periodontal tissues.
• Smoke ≥ 10 cigarettes/day.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle University of Thessaloniki, School of Dentistry

Thessaloniki, Thessaloniki, Greece

RECRUITING

Related Publications (1)

• - Graziani F, Karapetsa D, Mardas N, Leow N, Donos N (2018) Surgical treatment of the residual periodontal pocket. Periodontol 2000 76:150-163. - Lang NP, Salvi GE, Sculean A (2019) Nonsurgical therapy for teeth and implants-When and why? Periodontol 200079(1):15-21. doi: 10.1111/prd.12240. - Kaldahl WB, Kalkwarf KL, Patil KD, Molvar MP. Responses of four tooth and site groupings to periodontal therapy. J Periodontol. 1990 Mar;61(3):173-9. doi: 10.1902/jop.1990.61.3.173. PMID: 2181110. - Tomasi C, Leyland AH, Wennström JL. Factors influencing the outcome of non-surgical periodontal treatment: a multilevel approach. J Clin Periodontol. 2007 Aug;34(8):682-90. doi: 10.1111/j.1600-051X.2007.01111.x. PMID: 17635246. - Wang HL, Burgett FG, Shyr Y, Ramfjord S. The influence of molar furcation involvement and mobility on future clinical periodontal attachment loss. J Periodontol. 1994 Jan;65(1):25-9. doi: 10.1902/jop.1994.65.1.25. PMID: 8133412. - Nibali L, Zavattini A, Nagata K, Di Iorio A, Lin GH, Needleman I, Donos N. Tooth loss in molars with and without furcation involvement - a systematic review and meta-analysis. J Clin Periodontol. 2016 Feb;43(2):156-66. doi: 10.1111/jcpe.12497. Epub 2016 Feb 12. PMID: 26932323. - Meza Mauricio J, Furquim CP, Bustillos-Torrez W, Soto-Peñaloza D, Peñarrocha-Oltra D, Retamal- Valdes B, Faveri M (2021) Does enamel matrix derivative application provide additional clinical benefits in the treatment of maxillary Miller class I and II gingival recession? A systematic review and meta-analysis. Clin Oral Investig25(4):1613-1626. doi: 10.1007/s00784-021-03782-2. - Graziani F, Gennai S, Cei S, Ducci F, Discepoli N, Carmignani A, Tonetti M (2014) Does enamel matrix derivative application provide additional clinical benefits in residual periodontal pockets associated with suprabony defects? A systematic review and meta-analysis of randomized clinical trials. J Clin Periodontol;41(4):377-86. doi: 10.1111/jcpe.12218. - Stavropoulos A, Bertl K, Spineli LM, Sculean A, Cortellini P, Tonetti M (2021) Medium- and longterm clinical benefits of periodontal regenerative/reconstructive procedures in intrabony defects: Systematic review and network meta-analysis of randomized controlled clinical studies. J Clin Periodontol48(3):410-430. doi: 10.1111/jcpe.13409. - Esberg A, Isehed C, Holmlund A, Lundberg P (2019) Peri-implant crevicular fluid proteome before and after adjunctive enamel matrix derivative treatment of peri-implantitis. J Clin Periodontol46(6):669-677. doi: 10.1111/jcpe.13108. - Oliveira HFE, Verri F, Lemos CA, Cruz R, Batista VES, Pellizzer E, Santinoni C (2020) Clinical Evidence for Treatment of Class II Periodontal Furcation Defects. Systematic Review and Metaanalysis. J Int Acad Periodontol22(3):117-128. - Wennstrom JL, Lindhe J (2002) Some effects of enamel matrix proteins on wound healing in the dentogingival region. J Clin Periodontol29:9-14. - Mark R, Mohan R, Gundappa M, Balaji MDS, Vijay VK, Umayal M. Comparative Evaluation of Periodontal Osseous Defects Using Direct Digital Radiography and Cone-Beam Computed Tomography. J Pharm Bioallied Sci. 2021 Jun;13(Suppl 1):S306-S311. doi: 10.4103/jpbs.JPBS_804_20. Epub 2021 Jun 5. PMID: 34447099; PMCID: PMC8375921. - Assiri H, Dawasaz AA, Alahmari A, Asiri Z. Cone beam computed tomography (CBCT) in periodontal diseases: a Systematic review based on the efficacy model. BMC Oral Health. 2020 Jul 8;20(1):191. doi: 10.1186/s12903- 020-01106-6. PMID: 32641102; PMCID: PMC7341656. - Walter C, Schmidt JC, Rinne CA, Mendes S, Dula K, Sculean A. Cone beam computed tomography (CBCT) for diagnosis and treatment planning in periodontology: systematic review update. Clin Oral Investig. 2020 Sep;24(9):2943-2958. doi: 10.1007/s00784-020-03326-0. Epub 2020 Jul 3. PMID: 32617781. - Yusof NAM, Noor E, Reduwan NH, Yusof MYPM. Diagnostic accuracy of periapical radiograph, cone beam computed tomography, and intrasurgical linear measurement techniques for assessing furcation defects: a longitudinal randomised controlled trial. Clin Oral Investig. 2021 Mar;25(3):923-932. doi: 10.1007/s00784-020- 03380-8. Epub 2020 Jun 14. PMID: 32535703. - Zhang W, Foss K, Wang BY. A retrospective study on molar furcation assessment via clinical detection, intraoral radiography and cone beam computed tomography. BMC Oral Health. 2018 May 3;18(1):75. doi: 10.1186/s12903- 018-0544-0. PMID: 29724208; PMCID: PMC5934848.

  BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases; Furcation Defects

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Georgios S Chatzopoulos, DDS, MS

CONTACT

+30 6970836897; gschatzopoulos@gmail.com

Lazaros Tsalikis, Professor, DDS, PhD

CONTACT

+30 2310 999603; tsalikis@dent.auth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The selected sites will be randomly assigned to test and control groups using an online software for randomization. The therapist will be kept unaware of treatment allocation until the treatment. The outcomes assessor will be unaware of the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Model Details: Patients will be randomly allocated at a 1:1 ratio to either subgingival debridement and flapless application of EMD (test group) into the affected furcation defect or to periodontal surgery in combination with EMD application (control group). The selected sites will be randomly assigned to test and control groups using an online software for randomization. The therapist will be kept unaware of treatment allocation until the treatment.

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 15, 2022
• Study Start: October 15, 2022
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

GR (1)