| Abstract | Ciljevi: Cilj ovog presječnog istraživanja bio je istražiti stupanj težine parodontitisa u bolesnika s
opstrukcijskom apnejom tijekom spavanja (engl. Obstructive Sleep Apnea, OSA) te identificirati
čimbenike rizika povezane s težinom stupnja parodontitisa među pacijentima s OSA-om. Također,
cilj istraživanja bio je i procijeniti cjelovitost opisa glavnih terapijskih modaliteta obiju bolesti,
nekirurškog parodontološkog protokola (NPP) i primjene uređaja za potpomognuto disanje
tijekom spavanja (engl. Positive Airway Pressure, PAP) u registriranim kliničkim ispitivanjima i
odgovarajućim objavljenim znanstvenim člancima.
Materijali i metode: Ispitanici su podvrgnuti cjelonoćnoj polisomnografiji/poligrafiji iza čega su
upućeni na parodontološki pregled. Prema indeksu apneje i hipopneje (engl. Apnea Hypopnea
Index, AHI), pacijenti su podijeljeni na one bez OSA-e, s blagom OSA-om te umjerenom i teškom
OSA-om. Težina parodontitisa određena je razinom kliničkog pričvrstka (engl. clinical attachment
level, CAL), prema najnovijoj klasifikaciji parodontnih bolesti i stanja te su ispitanici s
parodontitisom podijeljeni u dvije skupine: one sa stadijem 1 i 2 te stadijem 3 i 4. Identificirana su
klinička ispitivanja prijavljena u registru ClinicalTrials.gov koja su provodila NPP te posebno ona
koja su koristila PAP terapiju. Zatim su se pretražili odgovarajući objavljeni članci identificiranih
kliničkih ispitivanja. Cjelovitost izvještavanja o intervencijama procijenjena je korištenjem
predloška za opis i primjenjivost intervencija (engl. Template for Intervention Description and
Replication, TIDieR). Intervencije uključene u analizu NPP-a bile su: upute o oralnoj higijeni,
profesionalno mehaničko uklanjanje plaka, subgingivna instrumentacija, antiseptici i antibiotici.
Analizirali su se i usporedili podaci iz protokola registra i objavljenih članaka što je uključivalo
karakteristike sudionika, kvalitetu opisa analiziranih intervencija te primarne i sekundarne ishode.
Rezultati: Više vrijednosti AHI zabilježene su u bolesnika s OSA-om koji su imali parodontitis
stadija 3 i 4 u usporedbi s OSA pacijentima s parodontitisom stadija 1 i 2 (P=0,043) i skupinom
bez parodontitisa (p=0,044). Nađena je pozitivna korelacija između AHI i CAL-a (r=0,215;
P=0,004), te između AHI-ja i količine plaka (r=0,292; P<0,001). AHI je bio značajan prediktor
CAL-a (β=0,169; P=0,031), zajedno s dobi (β=0,266; P=0,001), pušenjem (β=0,305; P<0,001) i
brojem posjeta doktoru dentalne medicine (β=-0,182; P=0,02). Opis intervencija NPP-a i PAP
terapije u registru na ClinicalTrials.gov i objavljenim člancima bio je neadekvatan za sve
analizirane intervencije. Također, pokazana je nedosljednost podataka iz registra u usporedbi s
podacima u objavljenim člancima. Odstupanja u karakteristikama ispitivanja između registra i objavljenih članaka uključivala su informacije o broju ispitanika, izračunu veličine uzorka i dobi
ispitanika, kao i informacije o primarnim i sekundarnim mjerama ishoda.
Zaključak: Pacijenti s uznapredovalim oblicima parodontitisa imaju teže oblike OSA-e. Povećani
CAL i količina plaka povezani su s većim vrijednostima AHI-ja, a AHI, uz dob i pušenje, je
značajan prediktor povećane vrijednosti CAL-a u pacijenata s OSA-om. Cjelovitost opisa NPP-a i
PAP terapije u kliničkim ispitivanjima je nezadovoljavajuća što smanjuje kvalitetu prevođenja
novih dokaza i postupaka u kliničku praksu. Značajna razlika u registriranim i prijavljenim
ishodima ispitivanja dovodi u pitanje valjanost prijavljenih rezultata i relevantnost za praksu. |
| Abstract (english) | Objectives: The aim of this cross-sectional study was to investigate the severity of periodontitis
in patients with obstructive sleep apnea (OSA) and to identify risk factors associated with the
severity of periodontitis among patients with OSA. Another aim of this study was to assess the
completeness of the description of the main therapeutic modalities of both diseases, the nonsurgical periodontal protocol (NPP) and positive airway pressure (PAP) therapy in registered
clinical trials and corresponding publications.
Materials and methods: The subjects underwent an all-night polysomnography/polygraphy, after
which they were referred for a periodontal examination. According to the apnea and hypopnea
index (AHI), patients were divided into those without OSA, with mild OSA, and moderate and
severe OSA. The severity of periodontitis was determined by the clinical attachment level (CAL),
according to the latest classification of periodontal diseases and conditions, and patients with
periodontitis were divided into two groups: those with stage 1 and 2 and those with stage 3 and 4.
Clinical trials were identified from the ClinicalTrials.gov registry that performed NPP and PAP
therapy, respectively. Published articles of identified clinical trials were then searched. The
completeness of intervention reporting was assessed using the Template for Intervention
Description and Replication (TIDieR). The interventions included in the NPP analysis were oral
hygiene instructions, professional mechanical plaque removal, subgingival instrumentation,
antiseptics and antibiotics. Data from the registry protocol and published articles were analyzed
and compared, which included the characteristics of the participants, the quality of the description
of the analyzed interventions and the primary along with secondary outcome measures.
Results: Higher AHI values were recorded in OSA patients who had stage 3 and 4 periodontitis
compared to OSA patients with stage 1 and 2 periodontitis (P=0.043) and the group without
periodontitis (P=0.044). A positive correlation was found between AHI and CAL (r=0.215;
P=0.004) and between AHI and plaque score (r=0.292; p<0.001). AHI was a significant predictor
of CAL (β=0.169; P=0.031) along with age (β=0.266; P=0.001), smoking (β=0.305; P<0.001) and
the number of dental visits (β=-0.182; P=0.02). The description of NPP and PAP therapy
interventions in the ClinicalTrials.gov registry and published articles was inadequate for all
analyzed interventions. The inconsistency of data from the registry compared to data in published
articles was also shown. Discrepancies in trial characteristics between the registry and published
articles included information on the number of subjects, sample size calculation and age of study
subjects, as well as information on primary and secondary outcome measures.
Conclusion: Patients with advanced forms of periodontitis, stage 3 and 4 have more severe forms
of OSA. Increased CAL and plaque amount are associated with higher AHI values, and AHI, along
with age and smoking, is a significant predictor of increased CAL values in patients with OSA.
The completeness of the description of NPP and PAP therapy in clinical trials is unsatisfactory,
which reduces the quality of translation of new evidence and procedures into clinical practice. The
significant difference in registered and reported trial outcome measures calls into question the
validity of the reported results and the relevance to practice. |
