Long-term Surgical Therapeutic Outcomes of Peri-Implantitis

Peri-Implantitis Clinical Trial

Official title:

Long-term Surgical Therapeutic Outcomes of Peri-Implantitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03772652
• Other study ID #: HUM00148346
• Status: Terminated
• Start date: December 4, 2018
• Est. completion date: February 13, 2020

Study information

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

Clinical Trial Summary

This study focuses on evaluating the success of different treatment methods for peri-implantitis (gum disease around implants) and to understand the factors that might affect the success of the treatment provided.

Description:

Qualifying patients will be asked to participate in clinical measurements to compare the long-term success of their treatments.

The aims of the current study are to 1) assess the long-term outcome of the surgical treatment of peri-implantitis and to 2) evaluate the success of the different treatment modalities of peri-implantitis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: February 13, 2020
• Est. primary completion date: February 13, 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 radiologically assessed marginal bone loss = 3 mm),

3. had received treatment for peri-implantitis at least 5 years ago at the Graduate Clinic of Periodontics at University of Michigan, and

4. documentation from = 5 years 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)

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 (25)

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

Canullo L, Peñarrocha M, Monje A, Catena A, Wang HL, Peñarrocha D. Association Between Clinical and Microbiologic Cluster Profiles and Peri-implantitis. Int J Oral Maxillofac Implants. 2017 Sep/Oct;32(5):1054-1064. doi: 10.11607/jomi.6043. — 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

Faggion CM Jr, Listl S, Tu YK. Assessment of endpoints in studies on peri-implantitis treatment--a systematic review. J Dent. 2010 Jun;38(6):443-50. doi: 10.1016/j.jdent.2010.03.003. Epub 2010 Mar 11. Review. — View Citation

Froum SJ, Rosen PS. A proposed classification for peri-implantitis. Int J Periodontics Restorative Dent. 2012 Oct;32(5):533-40. — View Citation

Javed F, Al-Askar M, Al-Rasheed A, Al-Hezaimi K. Significance of the platelet-derived growth factor in periodontal tissue regeneration. Arch Oral Biol. 2011 Dec;56(12):1476-84. doi: 10.1016/j.archoralbio.2011.06.020. Epub 2011 Jul 20. Review. — View Citation

Jung RE, Glauser R, Schärer P, Hämmerle CH, Sailer HF, Weber FE. Effect of rhBMP-2 on guided bone regeneration in humans. Clin Oral Implants Res. 2003 Oct;14(5):556-68. — 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

Klokkevold PR, Han TJ. How do smoking, diabetes, and periodontitis affect outcomes of implant treatment? Int J Oral Maxillofac Implants. 2007;22 Suppl:173-202. Review. Erratum in: Int J Oral Maxillofac Implants. 2008 Jan-Feb;23(1):56. — View Citation

Kotsovilis S, Karoussis IK, Trianti M, Fourmousis I. Therapy of peri-implantitis: a systematic review. J Clin Periodontol. 2008 Jul;35(7):621-9. doi: 10.1111/j.1600-051X.2008.01240.x. Epub 2008 May 11. Review. — View Citation

Lang NP, Berglundh T; Working Group 4 of Seventh European Workshop on Periodontology. Periimplant diseases: where are we now?--Consensus of the Seventh European Workshop on Periodontology. J Clin Periodontol. 2011 Mar;38 Suppl 11:178-81. doi: 10.1111/j.1600-051X.2010.01674.x. — View Citation

Li X, Wang X, Zhao T, Gao B, Miao Y, Zhang D, Dong Y. Guided bone regeneration using chitosan-collagen membranes in dog dehiscence-type defect model. J Oral Maxillofac Surg. 2014 Feb;72(2):304.e1-14. doi: 10.1016/j.joms.2013.09.042. Epub 2013 Oct 9. — View Citation

Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x. — 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

Mombelli A, Müller N, Cionca N. The epidemiology of peri-implantitis. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:67-76. doi: 10.1111/j.1600-0501.2012.02541.x. Review. — 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

Peri-implant mucositis and peri-implantitis: a current understanding of their diagnoses and clinical implications. J Periodontol. 2013 Apr;84(4):436-43. doi: 10.1902/jop.2013.134001. Review. — 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

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

Roos-Jansåker AM, Lindahl C, Persson GR, Renvert S. Long-term stability of surgical bone regenerative procedures of peri-implantitis lesions in a prospective case-control study over 3 years. J Clin Periodontol. 2011 Jun;38(6):590-7. doi: 10.1111/j.1600-051X.2011.01729.x. Epub 2011 Apr 13. — View Citation

Sanz M, Chapple IL; Working Group 4 of the VIII European Workshop on Periodontology. Clinical research on peri-implant diseases: consensus report of Working Group 4. J Clin Periodontol. 2012 Feb;39 Suppl 12:202-6. doi: 10.1111/j.1600-051X.2011.01837.x. — View Citation

Schou S, Holmstrup P, Jørgensen T, Stoltze K, Hjørting-Hansen E, Wenzel A. Autogenous bone graft and ePTFE membrane in the treatment of peri-implantitis. I. Clinical and radiographic observations in cynomolgus monkeys. Clin Oral Implants Res. 2003 Aug;14(4):391-403. — View Citation

Schou S, Holmstrup P, Skovgaard LT, Stoltze K, Hjørting-Hansen E, Gundersen HJ. Autogenous bone graft and ePTFE membrane in the treatment of peri-implantitis. II. Stereologic and histologic observations in cynomolgus monkeys. Clin Oral Implants Res. 2003 Aug;14(4):404-11. — View Citation

Schwarz F, Herten M, Sager M, Bieling K, Sculean A, Becker J. Comparison of naturally occurring and ligature-induced peri-implantitis bone defects in humans and dogs. Clin Oral Implants Res. 2007 Apr;18(2):161-70. Erratum in: Clin Oral Implants Res. 2007 Jun;18(3):397. — View Citation

Wiltfang J, Zernial O, Behrens E, Schlegel A, Warnke PH, Becker ST. Regenerative treatment of peri-implantitis bone defects with a combination of autologous bone and a demineralized xenogenic bone graft: a series of 36 defects. Clin Implant Dent Relat Res. 2012 Jun;14(3):421-7. doi: 10.1111/j.1708-8208.2009.00264.x. Epub 2010 Feb 3. — View Citation

* Note: There are 25 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.	At least five 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.	At least five 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.	At least five 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).	At least five years after the implant was treated for peri-implantitis