PARODONTITE

Treatment of Periodontal Defects Clinical Study


	Introduction
	The first clinical study on PD VitalOs Cement® was carried out in 2003 by Prof. H. Tenenbaum at the Faculty of Dental Surgery of the University of Strasbourg (France). The study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki. The protocol was reviewed by the CCPPRB Alsace I, the local Ethics Committee.
	Study objectives
	The objective of the study was to assess the safety and efficacy of PD VitalOs Cement® in the treatment of severe periodontitis and to compare it to the treatment with autologous graft. The primary end-point to assess efficacy was the clinical measurement of the attachment gain. Secondary clinical outcomes were also taken into consideration like pocket depth, gingival recession, dental plaque index and bleeding index.
	Methodology
	The study was longitudinal, prospective and randomized, comparing the use of PD VitalOs Cement® to autologous graft. A control treatment was used, where no material was implanted (only thorough cleaning, scaling and root planning). The patients enrolled were aged between 20 and 70, presenting two- to four-walls periodontal lesions. They all signed an informed consent before participating to the study. The study was carried out on 21 patients, all subject to severe periodontitis with at least three periodontal lesions involving the bone in the molar and pre-molar areas. Three treatments were compared: PD VitalOs Cement®, autograft, and control. Each patient received the three treatments, randomly distributed among the lesions (split-mouth design). The investigation was carried out over a period of 6 months including 5 visits: day 0 (day of surgery), day 7, day 30, day 90 and day 180, end of the treatment.
	Results
	The 21 patients completed the investigation over a period of 6 months without any major deviation from the protocol. For 60% of the implanted cases the results were positive, with good anchoring of the cement in situ and efficient healing of the periodontal tissues. PD VitalOs Cement® was perfectly tolerated and did not generate any inflammatory reaction, as evidenced by the comparison of inflammatory parameters resulting from the three treatments. The healing process of soft tissues in contact with PD VitalOs Cement® was neither delayed nor altered. Sequestration of the cement was noted in 40% of the cases: the fact that the cement was not yet presented in a dual syringe led to difficulties in mixing the powder and liquid properly and injecting the cement within the time allocated for this operation. Only when the preparation and injection of PD VitalOs Cement® was disturbed or when the treated tooth was excessively unstable, did the cement produce unsatisfactory results in terms of healing efficiency. These cases occurred without any pain for the patients. This result motivated Produits Dentaires S.A., the manufacturer, to present the cement in a dual syringe. The sequestration cases also showed that the mere application of the cement is not sufficient to ensure mechanical stabilisation of unstable teeth. For all treatments there were large fluctuations among patients, due to individual differences in healing capacity and bucco-dental hygiene. The primary end-point to assess efficacy was the attachment gain. The graphics above shows the results for the cases not disturbed by cement preparation issues or excessively unstable teeth.
	Conclusions
	As a conclusion, the use of PD VitalOs Cement® in the treatment of periodontal pockets of teeth that are not too mobile brings similar results to autograft, without requiring the additional step of harvesting graft. PD VitalOs Cement® is therefore proved to be a safe and efficient way to treat periodontal lesions.

/

/