Periodontal Treatment in Rheumatoid Arthritis Patients
Effects of Non-surgical Periodontal Therapy (NSPT) in Patients With and Without Rheumatoid Arthritis (RA)
Periodontitis is a chronic disease that leads to the loss of teeth. It has been associated to rheumatoid arthritis (RA). Periodontal therapy (NSPT) has been shown to have systemic effects. The objective of this study was to compare the effects of non-surgical periodontal therapy on biochemical parameters of rheumatoid arthritis (RA), periodontal parameters and quality of life in patients with and without RA.
Adult patients with and RA and periodontitis can participate in the study. Participants benefit from the effects of conventional tooth cleaning (periodontal therapy) and oral hygiene instructions. There are no significant risk associated with periodontal therapy.
The study is conducted at the Universidad de Antioquia in Medellin, Colombia. The study is set to start 2019 and end mid 2021. The study is funded by a grant from the Universidad de Antioquia. Contact person: Javier Enrique Botero (javier.botero@udea.edu.co)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
After participants are screened for inclusion, serum samples will be collected for the analysis of C-reactive protein (CRP; mg/L), rheumatoid factor (RF; UI/mL) and anti-citrullinated protein antibodies (ACPAs; UI/mL) in a reference laboratory. A complete periodontal chart will be carried out at six sites per tooth excluding third molars by a single experienced clinician using a calibrated probe (Hu-Friedy Mfg. Co.). Subgingival plaque samples will be collected by means of paper points inserted to the bottom of the pocket and processed immediately for culture analysis and detection of Porphyromonas gingivalis. RA patients will be examined by an experienced rheumatologist to determine their Disease Activity Score (DAS-28). All examinations will be taken at baseline and repeated 3 months after intervention.
Non-surgical periodontal therapy (NSPT) will be administered on the following 5 days of inclusion. A single 1-hour session of full-mouth debridement with an ultrasonic device will be carried out in each participant under local anesthesia by an experienced clinician. After NSPT is completed, each patient will receive oral hygiene instructions and oral care pack including toothbrush and toothpaste (toothbrush Vitis Encias Medium; Toothpaste Vitis Encias; Dentaid, Colombia).
Demographic ,clinical history as well as medication data for all participants will be collected. Periodontal parameters of PD (mm), PAL (mm) and BOP (%) will be recorded at each visit. The stage and grade of periodontitis will be established according to the new classification of periodontal diseases (Papapanou et al. 2018). The clinician who records data will not be blinded to the condition of the patients.
Sample size was calculated to detect a 50 % change in CRP with a power of >80% (alpha 0,05) which resulted in 15 per group (Cosgarea et al. 2018). Considering possible dropouts, 20 participants will be included per group. Randomization will not be performed since the purpose was to compare the effects of NSPT in patients with and without RA. The clinical investigator who records periodontal parameters will be calibrated for repeated measurements before patient inclusion (Kappa value was ≥0.80 for PAL and PD). Continuous variables will be presented as the mean and 95% confidence interval (CI) or median [interquartile range] when appropriate. Change in biochemical markers (CRP, RF, ACPAs) and periodontal parameters (PAL, PD, BOP, microbial counts) will be expressed as the delta (∆) from baseline to 3 months after intervention. Differences in means will be determined by the student t test for paired and unpaired samples or non-parametric tests when appropriate. Categorical variables will be presented as frequencies (%) and analyzed in contingency tables and X2. Logistic regression analysis for categorical variables and linear models will be used to test for associations and the odds ratio with 95%CI will be calculated. The primary analysis will be performed as intention to treat and then compared to per-protocol analysis results. The level of statistical significance will be set at 5% (P≤0,05).
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Antioquia
-
Medellin, Antioquia, Colombia, 00000
- Facultad de Odontología
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- age ≥ 18 years old; diagnosis of RA according to the American College of Rheumatology with DAS-28 score ≥ 3.2 and no change in RA medication in the previous 3 months;
- at least 15 teeth excluding third molars;
- ≥2 non-adjacent teeth interproximal sites with loss of periodontal attachment level (PAL) ≥ 2 mm; or buccal or oral PAL ≥3 mm with pocketing >3 mm is detectable at ≥2 teeth.
- Patients without RA met the same criteria except for the diagnosis of RA.
Exclusion Criteria:
- periodontal treatment or use of antibiotics in the previous 3 months.
- diabetes, liver disease, head and neck radiation therapy.
- pregnancy
- HIV
- use of cyclosporine.
- Smoking, use of hypertension and hyperlipidemia medication were not exclusion criteria and were recorded accordingly.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: group with rheumatoid arthritis
Non-surgical periodontal therapy (NSPT)
|
A single 1-hour session of full-mouth debridement with an ultrasonic device under local anesthesia
|
|
Altro: group without rheumatoid arthritis
Non-surgical periodontal therapy (NSPT)
|
A single 1-hour session of full-mouth debridement with an ultrasonic device under local anesthesia
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in C reactive protein
Lasso di tempo: 3 months
|
change in C-reactive protein levels (mg/L) measured as the difference between the baseline and 3-month examination.
|
3 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in rheumatoid factor (RF)
Lasso di tempo: 3 months
|
change in RF levels (UI/mL) measured as the difference between the baseline and 3-month examination.
|
3 months
|
|
Change in anti-citrullinated protein antibodies (ACPAs)
Lasso di tempo: 3 months
|
change in ACPA levels (UI/mL) measured as the difference between the baseline and 3-month examination
|
3 months
|
|
Change in periodontal attachment level (PAL)
Lasso di tempo: 3 months
|
change in PAL (mm) measured as the difference between the baseline and 3-month examination
|
3 months
|
|
Change in probing depth (PD)
Lasso di tempo: 3 months
|
change in PD (mm) measured as the difference between the baseline and 3-month examination
|
3 months
|
|
Change in bleeding on probing (BOP)
Lasso di tempo: 3 months
|
change in BOP (%) measured as the difference between the baseline and 3-month examination
|
3 months
|
|
Change in microbial counts
Lasso di tempo: 3 months
|
change in subgingival microbial counts (% total colony counts) measured as the difference between the baseline and 3-month examination
|
3 months
|
|
Change in quality of life
Lasso di tempo: 3 months
|
Change in The Short Form ( SF36) Health Survey measured as the difference between the baseline and 3-month examination.
It is converted to a 0-100 scale.The lower the score the more disability.
The higher the score the less disability.
|
3 months
|
|
Change in oral health profile
Lasso di tempo: 3 months
|
Change in Oral Health Impact Profile (OHIP-14) measured as the difference between the baseline and 3-month examination.
The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items.
Higher scores indicate worse and lower scores indicate better oral health quality of life.
|
3 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Javier E Botero, PhD, Universidad de Antioquia
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 05-2016
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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