Plain English Summary
Background and study aims
The aim of this study is to evaluate the healing following surgical periodontal treatment with a special decontamination method that contains a powder made of a special type of sugar (Erythritol). This method is compared with the traditional cleaning method using hand instruments.
Who can participate?
Patients with a tooth with one root that is in need of further periodontal surgical therapy
What does the study involve?
During surgery, the gingiva will be raised and all inflammation tissue will be removed. Patients will be randomly allocated to one of two treatment procedures: a) test treatment consisting of careful removal of calculus (if present) with the tip of a blade and subsequent decontamination of the diseased root surface with erythritol using an air-polishing device and b) control group treatment consisting of thorough mechanical cleaning with hand curettes and ultrasonic instruments. Depth of periodontal pockets, the level of the measurable gingival attachment, the measurable bone level in the mouth and on the x-ray will be evaluated before the surgery and 12 months after.
What are the possible benefits and risks of participating?
With either study treatment (test or control) there will be a resolution of the inflammation in the treated area (tooth with a remaining deep clinical periodontal pocket which is at high risk for further bone loss) and thus arrest the progression of periodontitis and bone loss. The risks for participating are the general risks as for any type of dental periodontal surgery: bleeding, swelling, pain, which are actually in good control since the surgical protocol includes tight suturing of the operated area, and painkillers if need.
Where is the study run from?
University of Medicine and Pharmacy Cluj-Napoca (Romania)
When is the study starting and how long is it expected to run for?
September 2013 to July 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Raluca Cosgarea
rcosgarea@umfcluj.ro
Trial website
Contact information
Type
Scientific
Primary contact
Dr Raluca Cosgarea
ORCID ID
http://orcid.org/0000-0003-2148-9645
Contact details
Str. Clinicilor nr 33
Cluj-Napoca
400506
Romania
+40 (0)751638904
rcosgarea@umfcluj.ro
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
#201
Study information
Scientific title
Healing following periodontal surgery and root surface decontamination by means of an erythritol based air-polishing
Acronym
CHIR_ERY
Study hypothesis
The clinical outcomes following conventional periodontal surgery (e.g. access flap using a simplified papilla preservation flap-SPPF) using the new erythritol powder applied with an air-polishing device are not inferior to those after the use of conventional hand and ultrasonic instruments in supra-alveolar bony defects.
Ethics approval
Approved 25/10/2013, Ethical Committee of the University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca (Str. Emil Isaac nr 13, Cluj-Napoca, Romania; Tel: +40 (0)264 597256; Email: gluminita@umfcluj.ro), ref: #201/25.19.2013
Study design
Prospective randomized controled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Periodontitis with horizontal bone loss
Intervention
Thirty systemically healthy patients with periodontitis are included in the present study. Inclusion criteria are the presence of a single-rooted tooth with a probing pocket depth (PD) ≥ 6 mm associated with horizontal bone loss as detected at re-evaluation following nonsurgical periodontal therapy.
These sites are in need for further surgical therapy. Following flap preparation by means of simplified papilla preservation flap (SPPF) and removal of granulation tissue, patients are randomized (according to a computer-generated list, block randomisation procedure) as follows:
1. Test treatment consisting of careful removal of calculus (if calculus present) with the tip of a blade and subsequent air-polishing of the root surfaces with erythritol air-polishing (EMS, Switzerland)
2. Control group treatment consisting of thorough scaling and root planing (SRP) with hand curettes and ultrasonic instruments
Parameters PD, clinical attachment (CAL), bone sounding (BS), and radiological bone level (BL) are evaluated at baseline and 12 months postsurgically. The primary outcome variable is CAL-gain.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Clinical attachment (CAL), measured with a periodontal probe (PCP UNC 15, Hu Friedy) from the bottom of the periodontal pocket to the cementum-enamel-junction, at baseline and 12 months
Secondary outcome measures
Measured at baseline and 12 months:
1. Periodontal pockets measured with a periodontal probe (PCP UNC 15, Hu Friedy) from the bottom of the periodontal pocket to the gingival margin
2. Bone sounding (BS) measured with a periodontal probe (PCP UNC 15, Hu Friedy) under anaesthesia in contact to the bone within the periodontal pocket to the gingival margin
3. Radiological bone level (BL) measured on x-rays as the distance from the most apical point of the intrabony defect to the cemento-enamel junction
Overall trial start date
15/09/2013
Overall trial end date
16/07/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients have to present one single-rooted tooth with a PD ≥ 6mm and horizontal bone loss with a maximum 2 mm intrabony component as detected radiographically (experimental tooth)
2. Over 18 years old
3. Completed the nonsurgical periodontal therapy (initial anti-infective therapy) at least 3 months prior to study inclusion or be in the corrective phase of the periodontal treatment or engaged in SPT
4. Maintain a good level of oral hygiene [plaque control record (PCR) after O’Leary 1972 ≤ 25%] (O'Leary et al., 1972)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Infectious/heart diseases that need prophylactic administration of antibiotics before dental treatments
2. History of diseases that may have influenced the severity/progression of periodontitis (e.g. Down Syndrome, HIV, Diabetes Mellitus type 1 and 2)
3. Liver diseases
4. Post-irradiation in the head/neck area
5. Periodontal surgery at the experimental teeth in the past 12 months
6. Clinical and/or radiographical signs of a vertical/horizontal tooth fracture or occlusal trauma at the test teeth
7. Pregnant or breastfeeding subjects
8. Patients smoking >10 cigarettes per day (Tonetti et al., 1995)
Recruitment start date
04/11/2013
Recruitment end date
14/12/2018
Locations
Countries of recruitment
Romania
Trial participating centre
University of Medicine and Pharmacy Cluj-Napoca
Department of Prosthodontics
Str Babes nr 8
Cluj-Napoca
400506
Romania
Sponsor information
Organisation
University of Medicine and Pharmacy Iuliu Hatieganu
Sponsor details
Department of Prosthodontics
Str. clinicilor nr 33
Cluj-Napoca
400506
Romania
+40 (0)264 597 256
contact@umfcluj.ro
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
A study protocol will not be available online. This will be provided only per request and a detailed description in the publication. Presentation at dental conferences and publication in specialized dental journals.
IPD sharing statement
The dataset will not be available online according to the data protection law. The data will be held on university computers and accessed only by authorized study persons.
Intention to publish date
16/07/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list