CLINICAL STUDIES ON THE ADMINISTRATION OF … ijmd nr 4-2011 final Popa.pdf · odontology, U.M.F....

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International Journal of Medical Dentistry 367 Abstract The aim of the study: The aim of the study was to determine whether the additional systemic treatment with 7 day course of Metronidazole® and Amoxycylin® significantly modified the results of non-surgical treat- ment in patients suffering from generalized aggressive periodontitis (PAG). Materials and method: The experimental group in- cluded 41 patients sufferring from PAG, with at least 3 sites at different teeth, and probing depth of the peri- odontal pockets (PPD) of 5-7 mm. The patients, divided into 2 groups, received identical recipients, containing either antibiotics or placebo. To the former group, first an antibiotic and then a placebo had been administered, while the latter received first placebo and then antibiot- ics. Results: The main result of the measurements per- formed in the study, quite significant in the former group, was a reduction of PPD in the sites with an initial PPD = 7 mm. Conclusions: The protocol of the present study per- mits the following conclusion: patients receiving antibi- otics as an initial therapy demonstrated significant im- provements, comparatively with those who were given such treatments after the etiological one. Keywords: aggressive periodontitis, antiinflammatory treatment, antibiotherapy INTRODUCTION Even if generalized aggressive periodontitis (PAG) affects only few patients with periodontal problems, it is very important, as it is character- ized by severe destructions of the periodontal tissues, which may provoke an early loss of teeth. Its relatively rare occurrence (1, 2) explains the scarce number of studies devoted to the com- plex treatment of such a periodontal pathology. Nowadays, it is generally known that, in most forms of periodontitis, the first step in a PAG treatment is of causal nature, aiming at reducing CLINICAL STUDIES ON THE ADMINISTRATION OF AMOXYCYLIN® AND METRONIDAZOLE® AS AN ADJUVANT TREATMENT IN GENERALIZED AGGRESSIVE PERIODONTITES Vanda Raluca Popa 1 , Sorina Solomon 2 , Ioana Rudnic 3 , Silvia Mârtu 4 1. Ph D student,Dept. Periodontology, Faculty of Med Dent, U.M.Ph. „Gr.T.Popa”, Iasi 2. Lecturer, PhDDept. Periodontology, Faculty of Med Dent, U.M.Ph. „Gr.T.Popa”, Iasi 3. Assit Prof. PhD., Dept. Periodontology, Faculty of Med Dent, U.M.Ph. „Gr.T.Popa”, Iasi 4. Prof. PhD., Dept. Periodontology, Faculty of Med Dent, U.M.Ph. „Gr.T.Popa”, Iasi Corresponding author: Martu Silvia, e-mail: [email protected] and/or eliminating the pathogeneous microor- ganisms. (3) More than that, some possible ad- vantage of systemic antibiotherapy, applied as early as the etiological phase of the therapy, was suggested. (4-6) THE AIM OF THE STUDY The aim of the study was to demonstrate that the adjuvant systemic 7 day cure with Metroni- dazole® and Amoxycylin® significantly modi- fied the results of non-surgical treatment in pa- tients suffering from generalized aggressive periodontitis (PAG). MATERIALS AND METHOD The experimental group was formed of the patients having addressed the DENT ESTET Clinics of Bucuresti and the Department of Peri- odontology, U.M.F. Iasi, between 2010-2011. Statistical analyses were performed and in- terpreted in the Department of Informatics and the Department of Periodontology – UMF Ia[i. The study observed the principles established by the Declaration of Helsinki on experiments developed with human patients. Each patient signed an informed consent. They were classi- fied as sufferring from either chronic or aggres- sive periodontitis, on the basis of the following criteria: aggressive periodontitis: the patient is clini- cally healthy – showing no systemic dis- eases that might favourize periodontitis; the radiographically observed bone loss is Periodontology

Transcript of CLINICAL STUDIES ON THE ADMINISTRATION OF … ijmd nr 4-2011 final Popa.pdf · odontology, U.M.F....

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International Journal of Medical Dentistry 367

AbstractThe aim of the study: The aim of the study was to

determine whether the additional systemic treatmentwith 7 day course of Metronidazole® and Amoxycylin®significantly modified the results of non-surgical treat-ment in patients suffering from generalized aggressiveperiodontitis (PAG).

Materials and method: The experimental group in-cluded 41 patients sufferring from PAG, with at least 3sites at different teeth, and probing depth of the peri-odontal pockets (PPD) of 5-7 mm. The patients, dividedinto 2 groups, received identical recipients, containingeither antibiotics or placebo. To the former group, first anantibiotic and then a placebo had been administered,while the latter received first placebo and then antibiot-ics.

Results: The main result of the measurements per-formed in the study, quite significant in the former group,was a reduction of PPD in the sites with an initial PPD =7 mm.

Conclusions: The protocol of the present study per-mits the following conclusion: patients receiving antibi-otics as an initial therapy demonstrated significant im-provements, comparatively with those who were givensuch treatments after the etiological one.

Keywords: aggressive periodontitis, antiinflammatorytreatment, antibiotherapy

INTRODUCTION

Even if generalized aggressive periodontitis(PAG) affects only few patients with periodontalproblems, it is very important, as it is character-ized by severe destructions of the periodontaltissues, which may provoke an early loss ofteeth. Its relatively rare occurrence (1, 2) explainsthe scarce number of studies devoted to the com-plex treatment of such a periodontal pathology.

Nowadays, it is generally known that, in mostforms of periodontitis, the first step in a PAGtreatment is of causal nature, aiming at reducing

CLINICAL STUDIES ON THE ADMINISTRATION OF AMOXYCYLIN®AND METRONIDAZOLE® AS AN ADJUVANT TREATMENT IN

GENERALIZED AGGRESSIVE PERIODONTITES

Vanda Raluca Popa1, Sorina Solomon2, Ioana Rudnic3, Silvia Mârtu4

1. Ph D student,Dept. Periodontology, Faculty of Med Dent, U.M.Ph. „Gr.T.Popa”, Iasi2. Lecturer, PhDDept. Periodontology, Faculty of Med Dent, U.M.Ph. „Gr.T.Popa”, Iasi3. Assit Prof. PhD., Dept. Periodontology, Faculty of Med Dent, U.M.Ph. „Gr.T.Popa”, Iasi4. Prof. PhD., Dept. Periodontology, Faculty of Med Dent, U.M.Ph. „Gr.T.Popa”, IasiCorresponding author: Martu Silvia, e-mail: [email protected]

and/or eliminating the pathogeneous microor-ganisms. (3) More than that, some possible ad-vantage of systemic antibiotherapy, applied asearly as the etiological phase of the therapy, wassuggested. (4-6)

THE AIM OF THE STUDY

The aim of the study was to demonstrate thatthe adjuvant systemic 7 day cure with Metroni-dazole® and Amoxycylin® significantly modi-fied the results of non-surgical treatment in pa-tients suffering from generalized aggressiveperiodontitis (PAG).

MATERIALS AND METHOD

The experimental group was formed of thepatients having addressed the DENT ESTETClinics of Bucuresti and the Department of Peri-odontology, U.M.F. Iasi, between 2010-2011.

Statistical analyses were performed and in-terpreted in the Department of Informatics andthe Department of Periodontology – UMF Ia[i.The study observed the principles establishedby the Declaration of Helsinki on experimentsdeveloped with human patients. Each patientsigned an informed consent. They were classi-fied as sufferring from either chronic or aggres-sive periodontitis, on the basis of the followingcriteria: 

– aggressive periodontitis: the patient is clini-cally healthy – showing no systemic dis-eases that might favourize periodontitis;the radiographically observed bone loss is

Periodontology

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368 volume 15 • issue 4 October / December 2011 •

higher than or equal to 50% in at least twodifferent teeth, while the age in the mo-ment of diagnosis was equal to or youngerthan 35 years;

– Moderate and severe periodontitis: attachmentloss larger or equal to 3 mm, and age ex-ceeding 35 years.

The patients with moderate or severe peri-odontitis were not considered in the study, be-ing selected 51 subhects diagnosed with PAG,according to the 1999 classification (Armitage)(4).

The study included patients with at least 20teeth present, good general condition and agesbetween 16-35 years. When first diagnosed assuffering from an aggressive periodontal dis-ease, the patients had at least 8 teeth and at leastan active site on probing the depth of the pocket(PPD) with continuous loss of attachment(LCAL) =5mm; (the ones with 3 or ore sites oc-curring at other teeth, and not at prime molarsand incissors).

10 patients were excluded from the experi-mental group, only 41 being accepted in the firststage of the study. All patients had at least 3 sitesat different teeth with pockets of 5-7mm. A weekafter patients’ selection, analyses of the clinicaland radiological evaluations were performedduring screening visits.

The patients of the two groups received iden-tical recipients, containing antibiotics and pla-cebo. (fig. 1)

in itial antibiotic(n20)

Antibiotic afteretiologic treatment…0,00%

50,00%

100,00%

medium age (95% CI)-30 yearswomen (%)smokers (%)

28.3 4%

80%

25%

29.35%57%

19%

initial antibiotic (n20)

Antibiotic after etiologictreatment (n21)

Fig. 1. Experimental group and clinical characteristicsof the 2 batches in the beginning of the investigation

All patients were treated along a 24 week-pe-riod, 38 of them being examined for other 2months after the secondary stage of the study(8 months in all).

PPD and the recessions of marginal gingiva(REC) were evaluated, and LCAL was calculatedas the sum between PPD and REC.

Clinical examination was performed in thebeginning of the first stage of the treatment, at 2,at 6 (second stage) and 8 months.

The 19 patients who took antibiotics when thetreatment was resumed recieved 2 recipientswith drugs. One recipient contained 21 capsulesof 500 mg Amoxycylin, the other – 21 capsules of500 mg Metronidazole. The pacients were askedto take one pill of each drug three times a day,for 7 days.

All patients used mouthwash solutions with0.2% chlorhexidine (for the optimization andstandardization of the initial compliance ofplaque control) for 2 weeks after the treatment,so that oral hygiene was maintained, as men-tioned in the beginning of the study.

The re-evaluation visits of the patients weremade 2 months after completing the secondarystage of the treatment and 8 months after theinitial examination. During this programming,the changes in the medical history of the patientswere recorded and the clinical periodontal pa-rameters registered during the initial visit wererepeated.

RESULTS AND DISCUSSION

The main result of the study was the reduc-tion of PPD in the sites with an initial PPD =7mm.

The secondary results referred to the differ-ences among groups for:

• modifications in the mean PPD and LCALin initially different PPD categories;

• modifications in the percents of sites, withPPD reduction = 2mm;

• percent of sites with PPD changed from =5to =4mm, and percent of sites with PPDmodified from =4 to =3mm;

• description and frequency of the adverseeffects;

• etiological therapy;• compliance with systemic medication.At 0-6 months, the etiological, singular

therapy (the placebo group) demonstrated a re-

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International Journal of Medical Dentistry 369

gression, while the adjuvant antibiotics demon-strated continuous optimization. (figs. 2, 3)

Fig. 2. Percent of sites increased with 2 mm versus thePPD level

Fig. 3. Percent of periodontal pockets reducedwith > 4mm, from < 3mm

The above graphs define values which repre-sent a PPD reduction = 2mm, or which show areduced number of pockets requiring treatment.

This result was interpreted as follows: for aPPD increase =5mm, surgical therapy will benecessary while, for a PPD increase = 4 mm af-ter initial therapy, etiological therapy is usuallyrequired.

At 0-6 months, the initial treatment indicatesan additional site optimization of 9%, throughreduction of PPD = 2mm, of 20% in the case ofsites modified from PPD = 5 to = 4 mm, and of18%, respectively, in the sites modified fromPPD =4 to =3mm. In this stage, the differenceswere statistically non-significant, as they re-ferred only to the cases of 0-2 months.

The best percent value referred to the modifi-cations produced over the 0-8 month period, thedifferences between the 2 groups being lower,and no significantly statistically differentcomparatively with the pockets = 5 mm, trans-formed into pockets = 4 mm (p = 0.041). (fig. 4)

Fig. 4. Percent of periodontal pockets reducedwith > 5 mm from < 4 mm

DISCUSSION

In the present study, the patients to whomplacebo was administered in the first stage ofthe placebo-control randomized clinical trial,were treated with antibiotics 6 months after theinitial debridement of the radicular surface(FMRSD). The second stage of the treatment wasorganized/structured so that the first patientsfinished their evaluation at 6 months, in the firststage of the study, prior to deconspiration.

In both phases, FMRSD was implementedalong 24 hours, to reduce the charge of periodon-tal pathogenic agents over a short time interval,and to prevent crossed contamination of thetreated sites (7).

Each treatment was followed by oral rinsingwith Clorhexidine (0.2%) for 2 weeks, in view ofanti-plaque activation, while patient’s hygieneat home could have been compromised.

The satisfactory compliance and the accept-able loyalty of the patients up to the end of the 8months of evaluation assured an at least 80%positiveness in detecting a real 1.0 mm differ-

CLINICAL STUDIES ON THE ADMINISTRATION OF AMOXYCYLIN® AND METRONIDAZOLE® AS AN ADJUVANTTREATMENT IN GENERALIZED AGGRESSIVE PERIODONTITES

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ence between groups, on the basis of the mainresulting variable.

Quite interestingly, the lag of the clinical re-sponse between groups was reduced when anti-biotics were administered to the group who re-ceived initially placebo. The mean percent valuesof the sites, with a reduction of the pockets= 2 mm and the percent of sites evidencingmodification of status – from “ill” to “healthy” –showed a similar pattern.

Even if the best result was observed at 8months, the most significant modification ap-peared between 0 and 2 months, whichever theapplied treatment. This agrees with the observa-tions of other studies dedicated to the effect ofthe mechanical non-surgical therapy, whichsuggests that the most significant changes oc-curred within 1-3 months from the administra-tion of the initial treatment (6,9).

At 8 months, 63% and 49% of the pockets thathad required treatment (= 4 mm) were firsttransformed into healthy sites (< 3 mm) after thetreatment, for the group with antibiotics admin-istered initially, and respectively, for the onewith antibiotics administered on re-evaluation.Consequently, as actually suggested by other au-thors (8, 9), the need for an invasive treatment,such as the surgical one, continuously decreases.

CONCLUSIONS

The protocol of the present study permits thefollowing conclusion: patients receiving antibi-otics as an initial therapy demonstrated signifi-cant improvements, comparatively with thosewho were given such treatments after theetiological one.

Both treatments optimized the average PPDand LCAL values, their positive modificationcontinuing, so that the maximum level was at-tained 8 months after the treatment.

References1. Cobb, C. M. (1996) Non-surgical pocket therapy, me-

chanical. Annals of Periodontology, 1: 443–490.2. Adriaens, P. A. & Adriaens, L. M. (2004) Effects of

nonsurgical periodontal therapy on hard and soft tis-sues. Periodontology 2000; 36: 121–145.

3. Suvan, J. E. (2005) Effectiveness of mechanical non-surgical pocket therapy. Periodontology 2000; 37:48–71.

4. Armitage, G. C. (1999) Development of a classifica-tion system for periodontal diseases of condi-tions. Annals of Periodontology; 4: 1–6.

5. Deas B.L., Mealey E. D. (2010), Response of chronicand aggressive periodontitis to treatment Periodon-tology 2000, Vol. 53: 154–166

6. Griffiths G. S., Ayob R., Guerrero A., Nibali L., J.Suvan, Moles D. R., (2011) Amoxicillin and met-ronidazole as an adjunctive treatment în general-ized aggressive periodontitis at initial therapy orre-treatment: a randomized controlled clinicaltrial J Clin Periodontol; 38: 43–49

7. Mestnik, M. J., Feres, M., Figueiredo, L. C., Duarte,P.M., Lira, E. A. & Faveri, M. (2010) Short-termbenefits of the adjunctive use of metronidazoleplus amoxicillin in the microbial profile and inthe clinical parameters of subjects with general-ized aggressive periodontitis. Journal of ClinicalPeriodontology; 37: 353–365.

8. Xajigeorgiou C., Sakellari, D., Slini, T., Baka, A.&Konstantinidis, A. (2006) Clinical and microbio-logical effects of different antimicrobials on general-ized aggressive periodontitis. Journal of ClinicalPeriodontology; 33: 254–264.

9. Herrera D., Alonso, B., Leo´n, R., Rolda´n, S. &Sanz,M. (2008) Antimicrobial therapy in periodonti-tis: the use of systemic antimicrobials against the sub-gingival biofilm. Journal of Clinical Periodontol-ogy;35 (Suppl. 8): 45–66.

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Vanda Raluca Popa, Sorina Solomon, Ioana Rudnic, Silvia Mârtu