The Effect of Smoking on Peri-implantitis

NCT06150066 | Active Not Recruiting

• 1 other identifier: 2023/GOA-8246
• Study Type: observational
• Target: 96
• Locations: 2 countries
• Sites: 2

Brief Summary

the primary aim of this project is to evaluate the microbiological and inflammatory effect of smoking status and smoking severity on periimplantitis lesions. The secondary aim is to compare the effect of smoking on periimplantitis and periodontal microbiota and inflammation in the same individuals. There will include 96 patients, equally divided into four groups: Smokers with peri-implantitis (n=24), non-smoker individuals with peri-implantitis (n=24), smokers with healthy peri-implant tissues (n=24), non-smoker individuals with healthy peri-implant tissues (n=24). Microbiological and biochemical analyses will be performed on the samples taken.

Conditions

Periimplantitis; Microbial Colonization; Cytokines

Outcome Measures

Primary Outcomes (10)

• The evaluation of the abundance of Fusobacterium nucleatum

  The presence and abundance of Fusobacterium nucleatum will be analysed by real-time Q-PCR in plaque samples

  2 months

• The evaluation of the abundance of Campylobacter rectus in plaque samples

  The presence and abundance of Campylobacter rectus will be analysed by real-time Q-PCR in plaque samples

  2 months

• The evaluation of the abundance of Prevotella intermedia in plaque samples

  The presence and abundance of Prevotella intermedia will be analysed by real-time Q-PCR in plaque samplse

  2 months

• The evaluation of the abundance of Aggregatinacter actinomycetemcomitans in plaque samples

  The presence and abundance of Aggregatinacter actinomycetemcomitans will be analysed by real-time Q-PCR in plaque samples

  2 months

• The evaluation of the abundance of Porphyromonas gingivalis in plaque samples

  The presence and abundance of Porphyromonas gingivalis will be analysed by real-time Q-PCR in plaque samples

  2 months

• The evaluation of the abundance of Tannerella forsythia in plaque samples

  The presence and abundance of Tannerella forsythia will be analysed by real-time Q-PCR in plaque samples

  2 months

• The evaluation of the abundance of Treponema denticola in plaque samples

  The presence and abundance of Treponema denticola will be analysed by real-time Q-PCR in plaque samples

  2 months

• The evaluation of the abundance of Saccharibacteria (TM7) in plaque samples

  The presence and abundance of Saccharibacteria (TM7) will be analyzed by real-time Q-PCR in plaque samplse

  2 months

• The evaluation of the abundance of Streptococcus aureus in plaque samples

  The presence and abundance of Streptococcus aureus will be analysed by real-time Q-PCR in plaque samples

  2 months

• The evaluation of the abundance of Actinomyces oris in plaque samples

  The presence and abundance of Actinomyces oris will be analysed by real-time Q-PCR in plaque samples

  2 months

Secondary Outcomes (4)

• The evaluation of 8-OHdG, PARK7/DJ-1, and NADPH oxidase levels in GCF and saliva samples

  2 months

• The evaluation of IL-1beta, IL-17A/E, and osteoprotegerin (OPG) levels in GCF and saliva samples

  2 months

• The evaluation of MMP-8 and MMP-3 levels in GCF and saliva samples

  2 months

• The evaluation of bone morphogenic protein (BMP)-2, epidermal growth factor (EGF), and vascular endothelial growth factor (VEGF) levels in GCF and saliva samples

  2 months

Study Arms (4)

Smokers with peri-implantitis

24 patients with smokers with peri-implantitis were included in this group.

Other: Recruiting samples

Non-smoker individuals with peri-implantitis

24 patients with non-smokers with peri-implantitis were included in this group.

Other: Recruiting samples

Smokers with healthy peri-implant tissues

24 patients with smokers with healthy peri-implant tissues were included in this group.

Other: Recruiting samples

Non-smoker individuals with healthy peri-implant tissues

24 patients with non-smokers with healthy peri-implant tissues were included in this group.

Other: Recruiting samples

Interventions

Recruiting samples OTHER

The GCF, plaque, and saliva samples will recruited from participants.

Non-smoker individuals with healthy peri-implant tissues; Non-smoker individuals with peri-implantitis; Smokers with healthy peri-implant tissues; Smokers with peri-implantitis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients, who come to the Dokuz Eylül, Gazi, and Ege University, Faculty of Dentistry, Department of Periodontology for routine periodontal control or treatment, will be included in the study.

You may qualify if:

• years old
• Body mass index (BMI) £30 kg/m
• Presence of min 1 implant and 1 tooth for the implant groups
• At least 1 year of implant loading for implant groups for the implant groups

You may not qualify if:

• Systemic diseases such as diabetes mellitus, hepatic or renal disease, or other medical conditions or transmittable diseases (ASA score III, IV, V)
• Pregnancy
• Having undergone antibiotics in the previous 6 months
• Periodontal treatment in the previous 6 months

Sponsors & Collaborators

• Mustafa Kemal University: lead
• University of Bern: collaborator
• Dokuz Eylul University: collaborator
• Gazi University: collaborator

Study Sites (2)

University of Bern

Bern, 3010, Switzerland

Location

Hatay Mustafa Kemal University

Antakya, Hatay, 31000, Turkey (Türkiye)

Location

Related Publications (35)

• Derks J, Ichioka Y, Dionigi C, Trullenque-Eriksson A, Berglundh J, Tomasi C, Graziani F. Prevention and management of peri-implant mucositis and peri-implantitis: A systematic review of outcome measures used in clinical studies in the last 10 years. Clin Oral Implants Res. 2023 May;34 Suppl 25:55-67. doi: 10.1111/clr.13925. Epub 2022 Jul 11.

  PMID: 35343614 BACKGROUND

• Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle 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.

  PMID: 29926491 BACKGROUND

• 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.

  PMID: 25495683 BACKGROUND

• Genco RJ. Current View of Risk Factors for Periodontal Diseases. J Periodontol. 1996 Oct;67 Suppl 10S:1041-1049. doi: 10.1902/jop.1996.67.10s.1041.

  PMID: 29539789 BACKGROUND

• Roccuzzo A, Stahli A, Monje A, Sculean A, Salvi GE. Peri-Implantitis: A Clinical Update on Prevalence and Surgical Treatment Outcomes. J Clin Med. 2021 Mar 6;10(5):1107. doi: 10.3390/jcm10051107.

  PMID: 33800894 BACKGROUND

• Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Clin Periodontol. 2018 Jun;45 Suppl 20:S246-S266. doi: 10.1111/jcpe.12954.

  PMID: 29926484 BACKGROUND

• Curtis MA, Diaz PI, Van Dyke TE. The role of the microbiota in periodontal disease. Periodontol 2000. 2020 Jun;83(1):14-25. doi: 10.1111/prd.12296.

  PMID: 32385883 BACKGROUND

• Marsh PD. Microbial ecology of dental plaque and its significance in health and disease. Adv Dent Res. 1994 Jul;8(2):263-71. doi: 10.1177/08959374940080022001.

  PMID: 7865085 BACKGROUND

• Buduneli N. Environmental factors and periodontal microbiome. Periodontol 2000. 2021 Feb;85(1):112-125. doi: 10.1111/prd.12355. Epub 2020 Nov 23.

  PMID: 33226700 BACKGROUND

• Axelsson P, Paulander J, Lindhe J. Relationship between smoking and dental status in 35-, 50-, 65-, and 75-year-old individuals. J Clin Periodontol. 1998 Apr;25(4):297-305. doi: 10.1111/j.1600-051x.1998.tb02444.x.

  PMID: 9565280 BACKGROUND

• de Araujo Nobre M, Mano Azul A, Rocha E, Malo P. Risk factors of peri-implant pathology. Eur J Oral Sci. 2015 Jun;123(3):131-9. doi: 10.1111/eos.12185. Epub 2015 Apr 20.

  PMID: 25894059 BACKGROUND

• Koldsland OC, Scheie AA, Aass AM. The association between selected risk indicators and severity of peri-implantitis using mixed model analyses. J Clin Periodontol. 2011 Mar;38(3):285-92. doi: 10.1111/j.1600-051X.2010.01659.x. Epub 2010 Dec 15.

  PMID: 21158898 BACKGROUND

• Romandini M, Lima C, Pedrinaci I, Araoz A, Soldini MC, Sanz M. Prevalence and risk/protective indicators of peri-implant diseases: A university-representative cross-sectional study. Clin Oral Implants Res. 2021 Jan;32(1):112-122. doi: 10.1111/clr.13684. Epub 2020 Dec 29.

  PMID: 33210772 BACKGROUND

• Farronato D, Azzi L, Giboli L, Maurino V, Tartaglia GM, Farronato M. Impact of Smoking Habit on Peri-Implant Indicators following Different Therapies: A Systematic Review. Bioengineering (Basel). 2022 Oct 18;9(10):569. doi: 10.3390/bioengineering9100569.

  PMID: 36290537 BACKGROUND

• Daubert DM, Weinstein BF, Bordin S, Leroux BG, Flemming TF. Prevalence and predictive factors for peri-implant disease and implant failure: a cross-sectional analysis. J Periodontol. 2015 Mar;86(3):337-47. doi: 10.1902/jop.2014.140438. Epub 2014 Nov 21.

  PMID: 25415249 BACKGROUND

• Lindquist LW, Carlsson GE, Jemt T. A prospective 15-year follow-up study of mandibular fixed prostheses supported by osseointegrated implants. Clinical results and marginal bone loss. Clin Oral Implants Res. 1996 Dec;7(4):329-36. doi: 10.1034/j.1600-0501.1996.070405.x.

  PMID: 9151599 BACKGROUND

• Karoussis IK, Salvi GE, Heitz-Mayfield LJ, Bragger U, Hammerle CH, Lang NP. Long-term implant prognosis in patients with and without a history of chronic periodontitis: a 10-year prospective cohort study of the ITI Dental Implant System. Clin Oral Implants Res. 2003 Jun;14(3):329-39. doi: 10.1034/j.1600-0501.000.00934.x.

  PMID: 12755783 BACKGROUND

• Schwarz F, Becker K, Sahm N, Horstkemper T, Rousi K, Becker J. The prevalence of peri-implant diseases for two-piece implants with an internal tube-in-tube connection: a cross-sectional analysis of 512 implants. Clin Oral Implants Res. 2017 Jan;28(1):24-28. doi: 10.1111/clr.12609. Epub 2015 Jul 14.

  PMID: 26178415 BACKGROUND

• Bizzarro S, Loos BG, Laine ML, Crielaard W, Zaura E. Subgingival microbiome in smokers and non-smokers in periodontitis: an exploratory study using traditional targeted techniques and a next-generation sequencing. J Clin Periodontol. 2013 May;40(5):483-92. doi: 10.1111/jcpe.12087. Epub 2013 Mar 13.

  PMID: 23489056 BACKGROUND

• Zhou N, Huang H, Liu H, Li Q, Yang G, Zhang Y, Ding M, Dong H, Mou Y. Microbiota analysis of peri-implant mucositis in patients with periodontitis history. Clin Oral Investig. 2022 Oct;26(10):6223-6233. doi: 10.1007/s00784-022-04571-1. Epub 2022 Jun 8.

  PMID: 35672515 BACKGROUND

• Chih SM, Cheng CD, Chen SH, Sung CE, Huang RY, Cheng WC. The impact of smoking on peri-implant microbiota: A systematic review. J Dent. 2023 Jun;133:104525. doi: 10.1016/j.jdent.2023.104525. Epub 2023 Apr 23.

  PMID: 37088258 BACKGROUND

• Tsigarida AA, Dabdoub SM, Nagaraja HN, Kumar PS. The Influence of Smoking on the Peri-Implant Microbiome. J Dent Res. 2015 Sep;94(9):1202-17. doi: 10.1177/0022034515590581. Epub 2015 Jun 29.

  PMID: 26124222 BACKGROUND

• Barbagallo G, Santagati M, Guni A, Torrisi P, Spitale A, Stefani S, Ferlito S, Nibali L. Microbiome differences in periodontal, peri-implant, and healthy sites: a cross-sectional pilot study. Clin Oral Investig. 2022 Mar;26(3):2771-2781. doi: 10.1007/s00784-021-04253-4. Epub 2021 Nov 26.

  PMID: 34826030 BACKGROUND

• Sari A, Davutoglu V, Bozkurt E, Taner IL, Erciyas K. Effect of periodontal disease on oxidative stress markers in patients with atherosclerosis. Clin Oral Investig. 2022 Feb;26(2):1713-1724. doi: 10.1007/s00784-021-04144-8. Epub 2021 Aug 20.

  PMID: 34415433 BACKGROUND

• Yamamoto Y, Nishida N, Tanaka M, Hayashi N, Matsuse R, Nakayama K, Morimoto K, Shizukuishi S. Association between passive and active smoking evaluated by salivary cotinine and periodontitis. J Clin Periodontol. 2005 Oct;32(10):1041-6. doi: 10.1111/j.1600-051X.2005.00819.x.

  PMID: 16174266 BACKGROUND

• SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

  PMID: 14158464 BACKGROUND

• LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

  PMID: 14121956 BACKGROUND

• Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.

  PMID: 1058834 BACKGROUND

• Caton JG, Armitage G, Berglundh T, Chapple ILC, Jepsen S, Kornman KS, Mealey BL, Papapanou PN, Sanz M, Tonetti MS. A new classification scheme for periodontal and peri-implant diseases and conditions - Introduction and key changes from the 1999 classification. J Periodontol. 2018 Jun;89 Suppl 1:S1-S8. doi: 10.1002/JPER.18-0157.

  PMID: 29926946 BACKGROUND

• Araujo MG, Lindhe J. Peri-implant health. J Clin Periodontol. 2018 Jun;45 Suppl 20:S230-S236. doi: 10.1111/jcpe.12952.

  PMID: 29926494 BACKGROUND

• Nibali L, Donos N. Periodontitis and redox status: a review. Curr Pharm Des. 2013;19(15):2687-97. doi: 10.2174/1381612811319150003.

  PMID: 23092320 BACKGROUND

• Varghese J, Bhat V, Chianeh YR, Kamath V, Al-Haj Husain N, Ozcan M. Salivary 8-hydroxyguanosine levels in smokers and non-smokers with chronic periodontitis. Odontology. 2020 Oct;108(4):569-577. doi: 10.1007/s10266-020-00496-x. Epub 2020 Feb 17.

  PMID: 32065311 BACKGROUND

• Sun Q, Shen ZY, Meng QT, Liu HZ, Duan WN, Xia ZY. The role of DJ-1/Nrf2 pathway in the pathogenesis of diabetic nephropathy in rats. Ren Fail. 2016;38(2):294-304. doi: 10.3109/0886022X.2015.1120119. Epub 2015 Dec 7.

  PMID: 26643903 BACKGROUND

• Yan YF, Yang WJ, Xu Q, Chen HP, Huang XS, Qiu LY, Liao ZP, Huang QR. DJ-1 upregulates anti-oxidant enzymes and attenuates hypoxia/re-oxygenation-induced oxidative stress by activation of the nuclear factor erythroid 2-like 2 signaling pathway. Mol Med Rep. 2015 Sep;12(3):4734-4742. doi: 10.3892/mmr.2015.3947. Epub 2015 Jun 17.

  PMID: 26081287 BACKGROUND

• Di Minno A, Turnu L, Porro B, Squellerio I, Cavalca V, Tremoli E, Di Minno MN. 8-Hydroxy-2-Deoxyguanosine Levels and Cardiovascular Disease: A Systematic Review and Meta-Analysis of the Literature. Antioxid Redox Signal. 2016 Apr 1;24(10):548-55. doi: 10.1089/ars.2015.6508.

  PMID: 26650622 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis; Communicable Diseases

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alpdogan Kantarci, Prof

  Forsyth Institute

  STUDY DIRECTOR

• Anton Sculean, Prof

  University of Bern

  STUDY CHAIR

• Berrin Unsal, Prof

  Gazi University

  STUDY CHAIR

• Aliye Akcali, Prof

  Dokuz Eylul University

  STUDY CHAIR

• Aysegul Sari, PhD

  Mustafa Kemal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Assistant professor

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: November 29, 2023
• Study Start: November 21, 2023
• Primary Completion: July 1, 2024
• Study Completion (Estimated): December 21, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

TU (1); CH (1)