Periodontitis Clinical Trial
Official title:
Vital Root-resective Therapy in Furcation-involved Maxillary Molars
Verified date | October 2023 |
Source | University of Santiago de Compostela |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 10 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria - 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 Exclusion Criteria 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) - Root trunk exceeding ½ of the total root length - Fused roots - Remaining furcation not accessible for self-performed oral hygiene - The presence of occlusal dysfunction as assessed by the examining clinician - Sinus floor anatomy limiting possible osseous resective surgery - Tooth mobility causing discomfort to the patient |
Country | Name | City | State |
---|---|---|---|
Spain | Facultad de Odontologia | Santiago De Compostela | Coruña |
Lead Sponsor | Collaborator |
---|---|
University of Santiago de Compostela |
Spain,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Haskell EW. Vital root resection on maxillary multi-rooted teeth. J South Calif Dent Assoc. 1966 Nov;34(11):509-12. No abstract available. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Tahmooressi K, Jonasson P, Heijl L. Vital root resection with MTA: a pilot study. Swed Dent J. 2016;40(1):43-51. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum In: J Clin Periodontol. 2019 Jul;46(7):787. — View Citation
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. — View Citation
* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tooth survival | Tooth present or absent after treatment (yes/no) | 1 year | |
Secondary | Probing pocket depth | Distance from gingival margin to deepest point of the pocket | 1 year | |
Secondary | Clinical attachment levels | Distance from CEJ to deepest point of the pocket | 1 year | |
Secondary | Radiographic bone levels | Periapical radiographs and/or CBCT | 1 year | |
Secondary | Pulpal response to sensitivity tests | Positive or negative response to electric and cold pulp tests (yes/no).
Cold stimulus (Endo-Frost; Roeko GmbH & Co - Coltène-Whaledent, Switzerland) will be applied on a sprayed cotton pellet to the cervical third of the buccal and palatal surfaces of isolated teeth after gentle air-drying and for up to 10 seconds per tooth. A negative response will be recorded when the subject fails to indicate a response on two consecutive occasions on each surface. Electric testing will be carried out following manufacturer instructions by placing the toothpaste-impregnated probe tip to the occlusal third of the tooth. A plastic interproximal matrix band will be used between teeth to prevent current conduction to the adjacent teeth. A negative response will be recorded when the tester reaches its maximum level on two consecutive occasions. |
1 year | |
Secondary | Clinical signs or symptoms indicative of periapical pathology | Periapical radiolucencies, sinus tract, swelling, tenderness to percussion, coronal discolouration, pain on biting, cold and heat lingering sensitivity, persistent or spontaneous dull throbbing pain | 1 year | |
Secondary | Formation of calicified tissue in the pulp exposure | Presence or absence of radio-opaque area over pulp exposure assessed on CBCT (yes/no) | 1 year | |
Secondary | Tooth mobility | Yes/no | 1 year | |
Secondary | Further treatment needed | e.g. repeated instrumentation, prosthetic intervention, etc | 1 year |
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