Association Between Smoking Habit and Peri-implant Diseases: a Case Control Study

NCT04952428 | Completed

• 1 other identifier: PER-ECL-2020-07
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

Although smoking has been proposed as well, as a risk factor/indicator for peri-implantitis, there is currently no conclusive evidence. The current literature confronts the inconclusive evidence of tobacco for a risk factor. Therefore, the aim of the present investigation is to determine the association between tobacco and peri-implantitis in sample of patients who had received therapy implant-supported restorative therapy in a university setting. The present study was designed as a retrospective case control study in a sample of patients with implant-supported restorative therapy 7-19 years after restorative phase. The study was conducted at the Clinica Universitaria d'Odontologia (CUO) in the Universitat Internacional de Catalunya (UIC) for 1 month and was performed following the principles outlined in the Declaration of Helsinki (revised, amended, and clarified in 2013. Prior to enrol the study a written informed consent was signed. Patients provided with implant-supported restorative therapy between 2001-2013 was selected from the UIC database. The sample was divided in three groups: healthy patients, patients with mucositis and patients with peri-implantitis. During the examination, the clinician reviewed with the patient the Information and Medication History Forms and record the anthropometric, socio-demographic and clinical information. An initial questionnaire was conducted to obtain information regarding age, gender, medical history, medication, and health behaviour. Candidates underwent an oral pathology examination and a full-mouth probing using a standardize pressure (20N) probe SONDA PA\_ON (Orange Dental®, Aspachstr, Biberach, Germany) to determine their periodontal and peri-implant status. All statistical analyses were performed with the package RStudio (V2.5). Descriptive characteristics regarding all the covariates were summarized. Periimplant bone loss (95% Confidence Interval - 95% CI) were calculated both at implant- and at patient-level. A multilevel regression model will be applied to evaluate the influence of some risk/protective indicators on the risk for peri-implant bone loss. Risk/protective indicators for periimplantitis will be studied using multilevel (mixed-effects) multivariate regression analyses (patient- and implant-level). Each potential indicator was tested individually by adding it to an empty model having as dependent variable the peri-implant status and testing the significance.

Conditions

Peri-Implantitis; Peri-implant Mucositis; Bone Loss, Alveolar

Keywords

Peri-implantitis, peri-implant mucositis, radiographic bone loss, smoking habit

Outcome Measures

Primary Outcomes (1)

• Predictive value of smoking habit on peri-implant diseases

  To determine the predictive value of tobacco and periimplantitis in a group of patients treated with implant therapy from 2001 to 2013 in Clinica Universitària d'Odotntologia de la Universitat Internacional de Catalunya.

  1 day

Secondary Outcomes (1)

• Association between tobacco and peri-implant disease

  1 day

Study Arms (3)

Peri-implant group

It is based on clinical and radiographic bone loss. Implants should have clinical inflammation in combination with bleeding on probing and/or suppuration, also progressive bone loss when compared with baseline radiograph shall be demonstrable, as well as an increase in probing pocket depth (PPD) from the baseline examination (Baseline record are referred to those obtained after definitive prosthesis delivery). In those cases where no baseline records were available, marginal bone loss \> 3mm and probing \> 6mm were stated as requirements (2).

Behavioral: Re-examination visit ("today visit")

Peri-implant mucositis group

The case definition of peri-implant mucositis it is based on clinical inflammation in combination with profuse bleeding on probing and/or suppuration with increasing of probing pocket depths and absence of bone loss beyond crestal bone level (initial remodelling) (2).

Behavioral: Re-examination visit ("today visit")

Healthy patients group

The case definition of peri-implant health was based on absence of clinical inflammation, lack of bleeding on probing and absence of bone loss following initial healing (\< 2mm) (2).

Behavioral: Re-examination visit ("today visit")

Interventions

Re-examination visit ("today visit") BEHAVIORAL

Re-examination visit ("today visit") A guidebook will be prepared to standardize procedures throughout the protocol, step by step, for all questionnaires and evidence collection. The data will be transferred to a computerized database. The clinician will review with the patient the Information and Medication History Forms and record the anthropometric, socio-demographic and clinical information. Candidates will undergo an oral pathology examination and a full-mouth manual probing using a periodontal probe SONDA PA\_ON (Orange Dental®, Aspachstr, Biberach, Germany) to determine their periodontal and peri-implant status. Clinical and radiographic examination will be performed. Moreover, signs as presence of suppuration, bleeding, redness, probing depth must be recorded at 6 sites per implant applying. As well, a specific survey about tobacco habits including modification of Fagestrom \& Richmond test will be conducted.

Healthy patients group; Peri-implant group; Peri-implant mucositis group

Eligibility Criteria

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

Study Population

Patients provided with implant-supported restorative therapy between 2001-2013 was selected from the UIC database.

You may qualify if:

• men and women over 18 years old,
• partially or totally edentulous patients with at least one implant placed at the university and loaded 7-19 years before,
• cemented, screwed or mechanically retained prosthesis,
• single, partial prostheses, and complete (fixed and removable),
• patients diagnose of peri-implant health and peri-implantitis and
• ability to understand study procedures.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Josep Martínez

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Related Publications (22)

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• Merli M, Bernardelli F, Giulianelli E, Toselli I, Moscatelli M, Pagliaro U, Nieri M. Inter-rater agreement in the diagnosis of mucositis and peri-implantitis. J Clin Periodontol. 2014 Sep;41(9):927-33. doi: 10.1111/jcpe.12291. Epub 2014 Aug 6.

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MeSH Terms

Conditions

Peri-Implantitis; Alveolar Bone Loss; Smoking

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: JMartinez

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 7, 2021
• Study Start: February 15, 2021
• Primary Completion: February 22, 2021
• Study Completion: June 30, 2021
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)