Vital Root-resective Therapy in Furcation-involved Maxillary Molars

NCT05259982 | Unknown

• 1 other identifier: Furca_2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to evaluate 1-year survival of maxillary molars with subclass C vertical furcation involvement after vital root resective therapy

Conditions

Periodontitis; Furcation Defects

Keywords

Periodontitis; Furcation

Outcome Measures

Primary Outcomes (1)

• Tooth survival

  Tooth present or absent after treatment (yes/no)

  1 year

Secondary Outcomes (8)

• Probing pocket depth

  1 year

• Clinical attachment levels

  1 year

• Radiographic bone levels

  1 year

• Pulpal response to sensitivity tests

  1 year

• Clinical signs or symptoms indicative of periapical pathology

  1 year

Study Arms (1)

Vital root resection

EXPERIMENTAL

Root resective surgery aiming to preserve pulp vitality

Procedure: Vital root resection

Interventions

Vital root resection PROCEDURE

Vital resection of root with attachment loss exceeding 2/3 of the root with the use of calcium silicate cement in the pulpal wound

Vital root resection

Eligibility Criteria

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

You may qualify if:

• Minimum of 12 teeth present
• Diagnosis of Severe Periodontitis stage III or IV (Tonetti et al., 2018)
• At least one maxillary molar with: i) degree II-III horizontal furcation involvement (Eickholz and Walter, 2018), ii) class C vertical furcation involvement (bone loss up to the apical third of root cones) (Tarnow and Fletcher, 1984, Tonetti et al., 2017), iii) residual probing pocket depths \> 5 mm, iv) maximum mobility degree I (Hamp et al., 1975) and v) not already accessible for self-performed oral hygiene
• Received a course of non-surgical periodontal therapy within the past six months
• Positive response to electric and cold testing

You may not qualify if:

• Patient:
• Full mouth plaque score \> 30%
• A course of antibiotics within the past 3 months
• Pregnant/lactating women
• Relevant medical history as evaluated by the examining clinician which may have the potential to affect periodontal surgical treatment (such as disease affecting clotting ability)
• Individuals on long-standing (2 or above years) supportive periodontal therapy (SPT) management plans
• Molar affected by FI:
• Ongoing endodontic pathology affecting the furcation-involved molar, as judged by the examining clinician
• Teeth associated with signs or symptoms indicative of pulpal or periapical pathology
• Evidence of coronal cracks upon root resection
• Previous periodontal surgical treatment to the furcation-affected molar within the previous 5 years
• Endodontically treated tooth
• Restorations affecting more than 2 walls or 1 cusp
• Molar tooth acting as a bridge abutment
• Planned for extraction (for strategic/restorative reasons)

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Sites (1)

Facultad de Odontologia

Santiago de Compostela, Coruña, 15782, Spain

Location

Related Publications (35)

• Albandar JM. A 6-year study on the pattern of periodontal disease progression. J Clin Periodontol. 1990 Aug;17(7 Pt 1):467-71. doi: 10.1111/j.1600-051x.1990.tb02346.x.

  PMID: 2403413 BACKGROUND

• Brizuela C, Ormeno A, Cabrera C, Cabezas R, Silva CI, Ramirez V, Mercade M. Direct Pulp Capping with Calcium Hydroxide, Mineral Trioxide Aggregate, and Biodentine in Permanent Young Teeth with Caries: A Randomized Clinical Trial. J Endod. 2017 Nov;43(11):1776-1780. doi: 10.1016/j.joen.2017.06.031. Epub 2017 Sep 14.

  PMID: 28917577 BACKGROUND

• Carnevale G, Di Febo G, Tonelli MP, Marin C, Fuzzi M. A retrospective analysis of the periodontal-prosthetic treatment of molars with interradicular lesions. Int J Periodontics Restorative Dent. 1991;11(3):189-205. No abstract available.

  PMID: 1802876 BACKGROUND

• Chen MX, Zhong YJ, Dong QQ, Wong HM, Wen YF. Global, regional, and national burden of severe periodontitis, 1990-2019: An analysis of the Global Burden of Disease Study 2019. J Clin Periodontol. 2021 Sep;48(9):1165-1188. doi: 10.1111/jcpe.13506. Epub 2021 Jul 7.

  PMID: 34101223 BACKGROUND

• Dommisch H, Walter C, Dannewitz B, Eickholz P. Resective surgery for the treatment of furcation involvement: A systematic review. J Clin Periodontol. 2020 Jul;47 Suppl 22:375-391. doi: 10.1111/jcpe.13241.

  PMID: 31912534 BACKGROUND

• Dopico J, Nibali L, Donos N. Disease progression in aggressive periodontitis patients. A Retrospective Study. J Clin Periodontol. 2016 Jun;43(6):531-7. doi: 10.1111/jcpe.12533. Epub 2016 May 2.

  PMID: 26878438 BACKGROUND

• Filipowicz F, Umstott P, England M. Vital root resection in maxillary molar teeth: a longitudinal study. J Endod. 1984 Jun;10(6):264-8. doi: 10.1016/S0099-2399(84)80060-6. No abstract available.

  PMID: 6590730 BACKGROUND

• Graetz C, Schutzhold S, Plaumann A, Kahl M, Springer C, Salzer S, Holtfreter B, Kocher T, Dorfer CE, Schwendicke F. Prognostic factors for the loss of molars--an 18-years retrospective cohort study. J Clin Periodontol. 2015 Oct;42(10):943-50. doi: 10.1111/jcpe.12460. Epub 2015 Oct 26.

  PMID: 26399690 BACKGROUND

• Guerrero A, Griffiths GS, Nibali L, Suvan J, Moles DR, Laurell L, Tonetti MS. Adjunctive benefits of systemic amoxicillin and metronidazole in non-surgical treatment of generalized aggressive periodontitis: a randomized placebo-controlled clinical trial. J Clin Periodontol. 2005 Oct;32(10):1096-107. doi: 10.1111/j.1600-051X.2005.00814.x.

  PMID: 16174275 BACKGROUND

• Hamp SE, Nyman S, Lindhe J. Periodontal treatment of multirooted teeth. Results after 5 years. J Clin Periodontol. 1975 Aug;2(3):126-35. doi: 10.1111/j.1600-051x.1975.tb01734.x.

  PMID: 1058213 BACKGROUND

• Hashem D, Mannocci F, Patel S, Manoharan A, Brown JE, Watson TF, Banerjee A. Clinical and radiographic assessment of the efficacy of calcium silicate indirect pulp capping: a randomized controlled clinical trial. J Dent Res. 2015 Apr;94(4):562-8. doi: 10.1177/0022034515571415. Epub 2015 Feb 20.

  PMID: 25710953 BACKGROUND

• Haskell EW. Vital root resection on maxillary multi-rooted teeth. J South Calif Dent Assoc. 1966 Nov;34(11):509-12. No abstract available.

  PMID: 5224492 BACKGROUND

• Haskell EW. Vital root resection. Oral Surg Oral Med Oral Pathol. 1969 Feb;27(2):266-74. doi: 10.1016/0030-4220(69)90182-0. No abstract available.

  PMID: 5249524 BACKGROUND

• Hegde S, Sowmya B, Mathew S, Bhandi SH, Nagaraja S, Dinesh K. Clinical evaluation of mineral trioxide aggregate and biodentine as direct pulp capping agents in carious teeth. J Conserv Dent. 2017 Mar-Apr;20(2):91-95. doi: 10.4103/0972-0707.212243.

  PMID: 28855754 BACKGROUND

• Huynh-Ba G, Kuonen P, Hofer D, Schmid J, Lang NP, Salvi GE. The effect of periodontal therapy on the survival rate and incidence of complications of multirooted teeth with furcation involvement after an observation period of at least 5 years: a systematic review. J Clin Periodontol. 2009 Feb;36(2):164-76. doi: 10.1111/j.1600-051X.2008.01358.x.

  PMID: 19207893 BACKGROUND

• Jepsen K, Dommisch E, Jepsen S, Dommisch H. Vital root resection in severely furcation-involved maxillary molars: Outcomes after up to 7 years. J Clin Periodontol. 2020 Aug;47(8):970-979. doi: 10.1111/jcpe.13306. Epub 2020 Jun 8.

  PMID: 32412133 BACKGROUND

• Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global Burden of Severe Tooth Loss: A Systematic Review and Meta-analysis. J Dent Res. 2014 Jul;93(7 Suppl):20S-28S. doi: 10.1177/0022034514537828.

  PMID: 24947899 BACKGROUND

• Linu S, Lekshmi MS, Varunkumar VS, Sam Joseph VG. Treatment Outcome Following Direct Pulp Capping Using Bioceramic Materials in Mature Permanent Teeth with Carious Exposure: A Pilot Retrospective Study. J Endod. 2017 Oct;43(10):1635-1639. doi: 10.1016/j.joen.2017.06.017. Epub 2017 Aug 12.

  PMID: 28807371 BACKGROUND

• Low KM, Dula K, Burgin W, von Arx T. Comparison of periapical radiography and limited cone-beam tomography in posterior maxillary teeth referred for apical surgery. J Endod. 2008 May;34(5):557-62. doi: 10.1016/j.joen.2008.02.022.

  PMID: 18436034 BACKGROUND

• Nibali L, Krajewski A, Donos N, Volzke H, Pink C, Kocher T, Holtfreter B. The effect of furcation involvement on tooth loss in a population without regular periodontal therapy. J Clin Periodontol. 2017 Aug;44(8):813-821. doi: 10.1111/jcpe.12756. Epub 2017 Jul 12.

  PMID: 28699678 BACKGROUND

• Nibali L, Yeh YC, Pometti D, Tu YK. Long-term stability of intrabony defects treated with minimally invasive non-surgical therapy. J Clin Periodontol. 2018 Dec;45(12):1458-1464. doi: 10.1111/jcpe.13021. Epub 2018 Nov 5.

  PMID: 30307641 BACKGROUND

• 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 BACKGROUND

• Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, Kosierkiewicz A, Kaczmarek W, Buczkowska-Radlinska J. Response of human dental pulp capped with biodentine and mineral trioxide aggregate. J Endod. 2013 Jun;39(6):743-7. doi: 10.1016/j.joen.2013.01.005. Epub 2013 Apr 10.

  PMID: 23683272 BACKGROUND

• Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S162-S170. doi: 10.1111/jcpe.12946.

  PMID: 29926490 BACKGROUND

• Papapanou PN, Tonetti MS. Diagnosis and epidemiology of periodontal osseous lesions. Periodontol 2000. 2000 Feb;22:8-21. doi: 10.1034/j.1600-0757.2000.2220102.x. No abstract available.

  PMID: 11276518 BACKGROUND

• Patel S, Wilson R, Dawood A, Foschi F, Mannocci F. The detection of periapical pathosis using digital periapical radiography and cone beam computed tomography - part 2: a 1-year post-treatment follow-up. Int Endod J. 2012 Aug;45(8):711-23. doi: 10.1111/j.1365-2591.2012.02076.x.

  PMID: 22775142 BACKGROUND

• Pretzl B, Eickholz P, Saure D, Pfefferle T, Zeidler A, Dannewitz B. Endodontic status and retention of molars in periodontally treated patients: results after 10 or more years of supportive periodontal therapy. J Clin Periodontol. 2016 Dec;43(12):1116-1123. doi: 10.1111/jcpe.12621. Epub 2016 Oct 17.

  PMID: 27570936 BACKGROUND

• Smukler H, Tagger M. Vital root amputation. A clinical and histological study. J Periodontol. 1976 Jun;47(6):324-30. doi: 10.1902/jop.1976.47.6.324.

  PMID: 1064719 BACKGROUND

• Svardstrom G, Wennstrom JL. Prevalence of furcation involvements in patients referred for periodontal treatment. J Clin Periodontol. 1996 Dec;23(12):1093-9. doi: 10.1111/j.1600-051x.1996.tb01809.x.

  PMID: 8997653 BACKGROUND

• Tahmooressi K, Jonasson P, Heijl L. Vital root resection with MTA: a pilot study. Swed Dent J. 2016;40(1):43-51.

  PMID: 27464381 BACKGROUND

• Tarnow D, Fletcher P. Classification of the vertical component of furcation involvement. J Periodontol. 1984 May;55(5):283-4. doi: 10.1902/jop.1984.55.5.283.

  PMID: 6588186 BACKGROUND

• Tonetti MS, Christiansen AL, Cortellini P. Vertical subclassification predicts survival of molars with class II furcation involvement during supportive periodontal care. J Clin Periodontol. 2017 Nov;44(11):1140-1144. doi: 10.1111/jcpe.12789. Epub 2017 Sep 22.

  PMID: 28771794 BACKGROUND

• Tonetti MS, Claffey N; European Workshop in Periodontology group C. Advances in the progression of periodontitis and proposal of definitions of a periodontitis case and disease progression for use in risk factor research. Group C consensus report of the 5th European Workshop in Periodontology. J Clin Periodontol. 2005;32 Suppl 6:210-3. doi: 10.1111/j.1600-051X.2005.00822.x. No abstract available.

  PMID: 16128839 BACKGROUND

• Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Clin Periodontol. 2018 Jun;45 Suppl 20:S149-S161. doi: 10.1111/jcpe.12945.

  PMID: 29926495 BACKGROUND

• White DA, Tsakos G, Pitts NB, Fuller E, Douglas GV, Murray JJ, Steele JG. Adult Dental Health Survey 2009: common oral health conditions and their impact on the population. Br Dent J. 2012 Dec;213(11):567-72. doi: 10.1038/sj.bdj.2012.1088.

  PMID: 23222333 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Furcation Defects

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• José L Dopico García, Dr

  Universidad de Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer

Study Record Dates

• First Submitted: February 6, 2022
• First Posted: March 2, 2022
• Study Start: March 4, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)