Periodontal surgery and root surface decontamination by means of an erythritol based air-polishing
| ISRCTN | ISRCTN41294401 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41294401 |
| Secondary identifying numbers | #201 |
- Submission date
- 29/10/2019
- Registration date
- 25/02/2020
- Last edited
- 28/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Scientific
Str. Clinicilor nr 33
Cluj-Napoca
400506
Romania
 ORCID ID |
0000-0003-2148-9645 |
|---|---|
| Phone | +40 (0)751638904 |
| rcosgarea@umfcluj.ro |
Study information
| Study design | Prospective randomized controled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Healing following periodontal surgery and root surface decontamination by means of an erythritol based air-polishing |
| Study acronym | CHIR_ERY |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 15/09/2013 |
| Completion date | 16/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key 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) |
| Key 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) |
| Date of first enrolment | 04/11/2013 |
| Date of final enrolment | 14/12/2018 |
Locations
Countries of recruitment
- Romania
Study participating centre
Str Babes nr 8
Cluj-Napoca
400506
Romania
Sponsor information
University/education
Department of Prosthodontics
Str. clinicilor nr 33
Cluj-Napoca
400506
Romania
| Phone | +40 (0)264 597 256 |
|---|---|
| contact@umfcluj.ro | |
| Website | http://www.umfcluj.ro/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 16/07/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/08/2020 | 28/03/2023 | Yes | No |
Editorial Notes
28/03/2023: Publication reference added.
21/02/2020: Trial's existence confirmed by the Ethical Committee of the University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca.
