Clinical Outcomes of Resective Surgical Treatment of Peri-Implantitis With or Without Implantoplasty

Peri-Implantitis Clinical Trial

Official title:

Clinical Outcomes of Resective Surgical Treatment of Peri-Implantitis With or Without Implantoplasty. A Retrospective Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04259840
• Other study ID #: HUM00169996
• Status: Terminated
• Start date: December 5, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: January 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aims of the current study are 1) to assess the therapeutic resolution of the peri-implantitis after resective surgical treatment with or without implantoplasty procedure (no further radiographic bone loss, no erythema of the peri-implant mucosa, PD <6mm), and 2) to evaluate the survival rate of the peri-implantitis treated dental implants.

Description:

The records of patients who underwent resective surgical treatment for peri-implantitis at the University of Michigan Graduate Periodontics clinic will be examined and analyzed. Patients who meet the inclusion/exclusion criteria will be contacted and invited to participate in the study to measure the following in a single visit: bleeding on probing, edema, redness of the peri-implant mucosa, and peri-implant probing pocket depth. Additionally, patients will be asked to complete a survey during their study visit regarding their implant(s) and previous peri-implantitis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: July 1, 2020
• Est. primary completion date: March 10, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. The patient is at least 18 years of age,

2. was initially diagnosed with peri-implantitis at =1 implant (peri-implant probing depth (PPD) = 6 mm together with bleeding and/or suppuration on probing (BOP/SoP) and bone loss progression over physiological bone remodeling radiologically assessed or marginal bone loss = 3 mm radiologically assessed in case of absence of baseline radiographs),

3. had received treatment for peri-implantitis at least 1 year ago at the Graduate Clinic of Periodontics at University of Michigan, and

4. documentation from = 1 year of clinical and radiological follow- up is available from U of M patients records.

Exclusion criteria:

1. Has received or is currently receiving radiotherapy,

2. are currently pregnant, unsure of their pregnancy status, or are lactating (as reported by the patient),

3. has health condition(s) or takes medication(s) that are known to affect soft tissue or bone (e.g., Phenytoin)

4. Received any kind of bone graft during the treatment of the peri-implantitis

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Other:
• Observation
Soft tissue implant measurements

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (21)

Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hämmerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957. — View Citation

Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hämmerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S313-S318. doi: 10.1002/JPER.17-0739. — View Citation

Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334. Review. — View Citation

Englezos E, Cosyn J, Koole S, Jacquet W, De Bruyn H. Resective Treatment of Peri-implantitis: Clinical and Radiographic Outcomes After 2 Years. Int J Periodontics Restorative Dent. 2018 Sep/Oct;38(5):729-735. doi: 10.11607/prd.3386. — View Citation

Hämmerle CHF, Tarnow D. The etiology of hard- and soft-tissue deficiencies at dental implants: A narrative review. J Clin Periodontol. 2018 Jun;45 Suppl 20:S267-S277. doi: 10.1111/jcpe.12955. Review. — View Citation

Heitz-Mayfield LJ. Peri-implant diseases: diagnosis and risk indicators. J Clin Periodontol. 2008 Sep;35(8 Suppl):292-304. doi: 10.1111/j.1600-051X.2008.01275.x. Review. — View Citation

Khoury F, Buchmann R. Surgical therapy of peri-implant disease: a 3-year follow-up study of cases treated with 3 different techniques of bone regeneration. J Periodontol. 2001 Nov;72(11):1498-508. — View Citation

Machtei EE. Treatment Alternatives to Negotiate Peri-Implantitis. Adv Med. 2014;2014:487903. doi: 10.1155/2014/487903. Epub 2014 Jun 15. Review. — View Citation

Monje A, Blasi G. Significance of keratinized mucosa/gingiva on peri-implant and adjacent periodontal conditions in erratic maintenance compliers. J Periodontol. 2019 May;90(5):445-453. doi: 10.1002/JPER.18-0471. Epub 2018 Dec 7. — View Citation

Monje A, Galindo-Moreno P, Tözüm TF, Suárez-López del Amo F, Wang HL. Into the Paradigm of Local Factors as Contributors for Peri-implant Disease: Short Communication. Int J Oral Maxillofac Implants. 2016 Mar-Apr;31(2):288-92. doi: 10.11607/jomi.4265. — View Citation

Monje A, Pons R, Insua A, Nart J, Wang HL, Schwarz F. Morphology and severity of peri-implantitis bone defects. Clin Implant Dent Relat Res. 2019 Aug;21(4):635-643. doi: 10.1111/cid.12791. Epub 2019 May 14. — View Citation

Monje A, Wang HL, Nart J. Association of Preventive Maintenance Therapy Compliance and Peri-Implant Diseases: A Cross-Sectional Study. J Periodontol. 2017 Oct;88(10):1030-1041. doi: 10.1902/jop.2017.170135. Epub 2017 May 26. — View Citation

Renvert S, Polyzois I, Claffey N. Surgical therapy for the control of peri-implantitis. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:84-94. doi: 10.1111/j.1600-0501.2012.02554.x. Review. — View Citation

Rimondini L, Farè S, Brambilla E, Felloni A, Consonni C, Brossa F, Carrassi A. The effect of surface roughness on early in vivo plaque colonization on titanium. J Periodontol. 1997 Jun;68(6):556-62. — View Citation

Roccuzzo M, De Angelis N, Bonino L, Aglietta M. Ten-year results of a three-arm prospective cohort study on implants in periodontally compromised patients. Part 1: implant loss and radiographic bone loss. Clin Oral Implants Res. 2010 May;21(5):490-6. doi: 10.1111/j.1600-0501.2009.01886.x. Epub 2010 Mar 11. — View Citation

Romeo E, Ghisolfi M, Murgolo N, Chiapasco M, Lops D, Vogel G. Therapy of peri-implantitis with resective surgery. A 3-year clinical trial on rough screw-shaped oral implants. Part I: clinical outcome. Clin Oral Implants Res. 2005 Feb;16(1):9-18. — View Citation

Romeo E, Lops D, Chiapasco M, Ghisolfi M, Vogel G. Therapy of peri-implantitis with resective surgery. A 3-year clinical trial on rough screw-shaped oral implants. Part II: radiographic outcome. Clin Oral Implants Res. 2007 Apr;18(2):179-87. — View Citation

Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350. Review. — View Citation

Schwarz F, Sahm N, Becker J. Combined surgical therapy of advanced peri-implantitis lesions with concomitant soft tissue volume augmentation. A case series. Clin Oral Implants Res. 2014 Jan;25(1):132-6. doi: 10.1111/clr.12103. Epub 2013 Jan 27. — View Citation

Schwarz F, Sahm N, Schwarz K, Becker J. Impact of defect configuration on the clinical outcome following surgical regenerative therapy of peri-implantitis. J Clin Periodontol. 2010 May;37(5):449-55. doi: 10.1111/j.1600-051X.2010.01540.x. Epub 2010 Mar 24. — View Citation

Zitzmann NU, Berglundh T. Definition and prevalence of peri-implant diseases. J Clin Periodontol. 2008 Sep;35(8 Suppl):286-91. doi: 10.1111/j.1600-051X.2008.01274.x. Review. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic resolution of the peri-implantitis as measured by radiographic bone loss	The implant has no further radiographic bone loss when compared to previous radiographs.	Up to 30 years after the implant was treated for peri-implantitis
Primary	Therapeutic resolution of the peri-implantitis as measured by erythema	The implant has no current erythema of the peri-implant mucosa.	Up to 30 years after the implant was treated for peri-implantitis
Primary	Therapeutic resolution of the peri-implantitis as measured by probing depths	The implant has probing depths less than or equal to 5 millimeters.	Up to 30 years after the implant was treated for peri-implantitis
Primary	Survival rate of the peri-implantitis treated dental implants	Survival rate will be determined by the duration of implant survival (functioning, non-symptomatic implant after peri-implantitis treatment).	Up to 30 years after the implant was treated for peri-implantitis