Non-surgical therapy in addition to three or seven days of amoxicillin and metronidazole treatment in patients with severe gum infection (periodontitis)
| ISRCTN | ISRCTN55637591 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55637591 |
| Secondary identifying numbers | 398/3.7.2015 |
- Submission date
- 22/02/2021
- Registration date
- 24/02/2021
- Last edited
- 30/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Periodontitis is a severe gum infection that can lead to tooth loss and other serious health complications. Periodontitis, also called gum disease, is a serious gum infection that damages the soft tissue and, without treatment, can destroy the bone that supports your teeth.
Studies evaluating the clinical, microbiological and immunological efficacy of a short-term administration of amoxicillin (AMX) and metronidazole (MET) for aggressive periodontitis are scarce.
The aim of the study is to evaluate the clinical, immunological, microbiological effect after 3, 6 and 12 months following non-surgical periodontal therapy in conjunction with the adjunctive use of AMX+MET administered for 3 or 7 days in patients with stage III to IV grade C periodontitis (aggressive periodontitis).
Who can participate?
Adults over 18 years with untreated aggressive periodontitis, that are otherwise healthy.
What does the study involve?
After receiving treatment for periodontitis using the usual methods, participants will be randomly allocated to receive either 3 or 7 days of antibiotics to aid recovery. Participants will be followed up for 12 months.
What are the possible benefits and risks of participating?
The patients receive periodontal treatment, periodontal inflamation will be eliminated and diseases progression will be stopped.
Possible side-effects are those related to antibiotic intake: gastro-intestinal disorders, allergic reactions, headache, taste disorders, vertigo; sideeffects related to non-surgical periodontal treatment: bleeding, pain, tooth hypersinsetivity.
Where is the study run from?
The Clinic for Prosthodontics, University Iuliu Hatieganu Cluj-Napoca (Romania)
When is the study starting and how long is it expected to run for?
March 2015 to December 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr. Raluca Cosgarea
ralucacosgarea@gmail.com
Contact information
Scientific
Policlinic for Prosthodontics
Str Clinicilor nr 32
Cluj-Napoca
400506
Romania
 ORCID ID |
0000-0003-2148-9645 |
|---|---|
| Phone | +40 751638904 |
| Raluca.cosgarea@ukbonn.de |
Study information
| Study design | Prospective randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN55637591_PIS.pdf |
| Scientific title | Short-term systemic antibiotics in periodontal treatment in patients suffering from aggressive periodontitis |
| Study acronym | AB-AgP |
| Study hypothesis | The non-surgical periodontal therapy (performed within 24 hours) in conjunction with adjunctive administration of systemic amoxicillin and metronidazole for a period of either 3 or 7 days in patients with severe aggressive periodontitis provide comparable clinical results. |
| Ethics approval(s) | Approved 02/07/2015, Ethical Committee of the Faculty of Medicine and Pharmacy of Iuliu-Hatieganu University Cluj-Napoca (Str. Victor Babes nr 8, Cluj-Napoca, Romania; +40-264-597256; etica.cercetare@umfcluj.ro), ref: 398/3.7.2015 |
| Condition | Non-surgical treatment of aggressive periodontitis |
| Intervention | - All patients receive oral hygiene instructions and professional supragingival cleaning sessions until a full-mouth plaque score (FMPS) ≤25% is obtained. - Thereafter, subgingival debridement (SD) is performed within 2 consecutive days at all sites with PD ≥4 mm with Gracey curets and ultrasonic instruments; - After SD, patients are instructed to rinse for the following 2 weeks with chlorhexidine digluconate 0.2% solution and brush their teeth with chlorhexidine-digluconate toothpaste. - At the end of the last SD session, patients are allocated to one of the two treatment groups: Amoxicillin + metronidazole both 500 mg three times a day (TID) for 3 days (Group A) Amoxicillin + metronidazole both 500 mg TID for 7 days (Group B) A computer-generated randomisation list (block-randomisation) is used. The following clinical parameters are assessed at baseline, at 3, 6 and 12 months: probing pocket depths (PPD), clinical attachment level (CAL), furcation involvement (FI), bleeding on probing (BOP), full mouth plaque scores (PCR). Additionally, subgingival samples for microbiological [A.actinomicetemcomitans (A.a.), P.gingivalis (P.g.), T.forsythia (T.f.), P.intermedia (P.i.), T.denticola (T.d.), P.micra (P.m.), F.alocis (F.a.), C.rectus (C.r.)] and inflammatory markers (IL-1β, IL-8, IL-10, MMP-8) analyses will be performed. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Amoxicillin, metronidazole |
| Primary outcome measure | Number of residual deep sites with probing depth ≥6 mm at 6 and 12 months |
| Secondary outcome measures | Measured at baseline, 6 and 12 months: 1. Probing pocket depths measured using patient records 2. Clinical attachment level measured using patient records 3. Bleeding on probing measured using patient records 4. Full-mouth plaque scores measured using patient records 5. Quantitative changes in investigated bacteria and inflammatory markers (sterile paper points were introduced in periodontal pockets, and then by real-time PCR and analysed using metagenome shotgun sequencing + metagenomic microbiome sequencing (for microbiology) and by ELISA test (for immunology)) |
| Overall study start date | 10/03/2015 |
| Overall study end date | 01/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 50 |
| Participant inclusion criteria | 1. Age 18 - 36 years 2. ≥12 natural teeth present in the oral cavity distributed in all four quadrants 3. Clinical signs of stage III and IV grade C Periodontitis (Tonetti et al 2018) (previous aggressive periodontitis) (Armitage. 1999): interdental CAL loss ≥5 mm, tooth loss die to periodontitis ≤ or ≥4 teeth, min. one PD ≥6 mm in each quadrant 4. Radiographic signs of stage III and IV grade C Periodontitis (Tonetti et al 2018): radiographic bone loss to middle or appical third of the root, vertical bone loss ≥3mm, % bone loss/age >1, or ≥2 mm bone loss in the past 5 years when older x-rays are present 5. Full-mouth plaque scores (FMPS) ≤25% (O'Leary et al. 1972) 6. Systemically healthy, i.e. absence of a known condition that may influence the severity or progression of periodontal disease (e.g. Down syndrome, HIV, diabetes mellitus type 1 and 2) 7. No head and neck radiation therapy 8. No infectious or heart diseases that need prophylactic administration of antibiotics before dental treatment 9. No liver disease |
| Participant exclusion criteria | 1. Non-surgical periodontal therapy within the previous 12 months 2. Systemic or local use of antibiotics within the previous 6 months 3. Any type of systemic medication within the previous 6 months 4. Pregnancy or lactation 5. Smoking >10 cigarettes/day |
| Recruitment start date | 01/09/2015 |
| Recruitment end date | 01/09/2018 |
Locations
Countries of recruitment
- Romania
Study participating centre
Cluj-Napoca
400506
Romania
Sponsor information
University/education
str Clinicilor nr 32
Cluj-Napoca
400506
Romania
| Phone | +40 751638904 |
|---|---|
| rcosgarea@umfcluj.ro | |
| Website | http://www.umfcluj.ro/en/ |
"ROR" |
https://ror.org/051h0cw83 |
University/education
Clinic of Periodontology
Dental School
Freiburgstrasse 7
Bern
3010
Switzerland
| Phone | +41 (0)31 632 25 77 |
|---|---|
| anton.sculean@zmk.unibe.ch | |
| Website | http://www.unibe.ch/eng/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/03/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 2-3 planned publications in high-impact peer-reviewed journals and presentation at congresses. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 01/03/2021 | No | Yes | ||
| Protocol file | 01/07/2015 | 01/03/2021 | No | No | |
| Results article | results | 21/08/2022 | 30/03/2023 | Yes | No |
Additional files
- ISRCTN55637591_PIS.pdf
- Uploaded 01/03/2021
- ISRCTN55637591_PROTOCOL_01July2015.pdf
- Uploaded 01/03/2021
Editorial Notes
30/03/2023: Publication reference added.
01/03/2021: The following changes have been made:
1. Uploaded protocol, 01 July 2015 (not peer reviewed) as an additional file.
2. Uploaded participant information sheet as an additional file.
23/02/2021: Trial’s existence confirmed by Iuliu-Hatieganu University Cluj-Napoca.
