Peri-ImplantitisNCT03241953
COMPARISION OF DIFFERENT TREATMENT METHODS OF PERI-IMPLANTITIS
A study testing Periodontal surgery in people with Peri-Implantitis and Periodontal Diseases, run by Necmettin Erbakan University.
Trial summary
In this randomized, controlled study, 18 patients with peri-implantitis were included. A total of forty dental implants were debrided with either ultrasonic instruments (test, n=20) or plastic scaler (control, n=20). Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Periodontal Diseases
- What is being tested?
- Periodontal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 23 Apr 2014to 22 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patients, who were systemically and periodontally healthy and free of parafunctional habits like bruxism, and didn't have any kind of periodontal therapy within the previous year and had implants for at least 5 years, were included in the study.
Who cannot join
- The patients with chronic bronchitis or asthma and major systemic illnesses (i.e. diabetes mellitus, cancer, HIV, bone metabolic diseases or disorders that compromise wound healing, radiation or immunosuppressive therapy) and those who had taken antibiotics, anti-inflammatory drugs or other medication within the previous 28 days were excluded in the study.
About this study
In this randomized, controlled study, 18 patients with peri-implantitis were included. A total of forty dental implants were debrided with either ultrasonic instruments (test, n=20) or plastic scaler (control, n=20). Gingival recession depth (RD), keratinized tissue width (KTW), probing depth (PD), Gingival Index (GI) were evaluated at baseline and after 6 months. CBCT radiographs were used to evaluate peri-implant bone loss. Supportive and nonsurgical periodontal therapies were firstly consulted to reduce the inflammation, occurring due to the surgical treatments of the defects. The formation of bacterial biofilm on implant surfaces was removed by ultrasonic scaler and air polishing using abrasive powders or conventional plastic scaler with klorhegsidin combination.
Read the detailed description
Subject selection 18 systemically healthy patients, who applied to the Department of Periodontology, Necmettin Erbakan University and whose at least 1 dental implant was diagnosed by peri-implantitis and who has never taken peri-implantitis therapy, were included in the study. All patients were informed about the study and given informed consent form, and only volunteers were included. The research was conducted in accordance with the principles outlined in the Declaration of Helsinki. This prospective clinical study was approved by the Research Ethics Committee of Necmettin Erbakan University.
The patients, who were systemically and periodontally healthy and free of parafunctional habits like bruxism, and didn't have any kind of periodontal therapy within the previous year and had implants for at least 5 years, were included in the study. In addition, the inclusion criteria were as follows: having pocket depth over 5mm in implants diagnosed by peri-implantitis (Figure 1), having no mobility, having bone loss in implant site that is needed for augmentation(Figure 2). The patients with chronic bronchitis or asthma and major systemic illnesses (i.e. diabetes mellitus, cancer, HIV, bone metabolic diseases or disorders that compromise wound healing, radiation or immunosuppressive therapy) and those who had taken antibiotics, anti-inflammatory drugs or other medication within the previous 28 days were excluded in the study.
18 patients (mean age 52 years) diagnosed by peri- implantitis were included in this randomized and controlled study. A total of forty dental implants were debrided with either standard plastic curettes, debridement made by combined klorhegsidin rinse(control, n=20) or mechanical debridement made by ultrasonic polyetheretherketone coated tips developed for implant surface and combined air-flow debridement (test, n=20).
Clinical Measurements The clinical parameters given below were observed on six sites of all implants: Plaque Index (PlI; Silness \& Lo€e 1964), PD, Bleeding upon Probing (BOP) and Gingival Recession (RD; gingival margin location measuremant cemento- enamel junction to Gingival marjin).
On six sites of all implants, the following clinical parameters were recorded: Plaque Index (PlI; Silness \& Lo€e 1964), PD, Bleeding on Probing (BOP) and Gingival Recession (RD; gingival margin location measuremant cemento- enamel junction to Gingival marjin).
Keratinized tissue width (KTW) was measured at buccal midpoint of implants. Bone loss volume was recorded on con-beam computed tomographs (CBCT) by measuring the distance from bone implant abutment placement to alveolar bone level. All measurements were taken at the beginning. As we didn't perform any regenerative operations and didn't want the patients to be subjected to X-rays again, no more tomographs were taken.
Phase I Periodontal Therapy Upon the recordings, all patients were given Phase 1 periodontal therapy and informed about hygiene control. Prior to surgical operation, professional supragingival and subgingival debridement was performed during 2 or 4 appointments. The patients with a good level of oral hygiene were included in the study. Oral hygiene controls were performed in the first, third and sixth months prior to and after operations. Occlusion controls of all implant supported dental prosthesis were performed, and if present, extreme contacts were removed.
Phase II Periodontal Therapy 4 weeks after the initial periodontal treatments, for the treatment of the sites with pocket depth deeper than 5mm, flap operation was performed to achieve a direct reach to implant surfaces. Around affected implants, intrasulcular incisions were performed and mucoperiostal flaps with full thickness were raised both buccally and palatally. Implant surface decontamination is performed using with either plastic curettes or ultrasonic scaler (Figure 3); In control group, plastic curettes (Hue-Friedy Co., Chicago, IL, USA) were used for debridement and implant surfaces were decontaminated by klorhegsidin solution. In test group, sub-gingival operations with ultrasonic scaler was for nearly 20s per site (EMS Master Piezon LED, implant care system, Nyon, Switzerland). A special design disposable thermoplastic elastomer nozzle (Perio-flow Nozzle EMS Electro Medical Systems, Nyon, Sweden.), which horizontally gives out the glycine powder, was utilized.
The hand-device (Air-Flows EL-308/A; EMS Electro Medical Systems, Nyon, Sweden) was used in a circular motion, from coronal to apical, parallel to the implant surface in a noncontact mode. The operation period time at each aspect (i.e. mesial, distal, vestibular and oral) was limited to 5 s, as suggested by the manufacturer 35. The nozzle was moved with a circumferential movement around the implant to cover the entire exposed implant surface (36).
After the debriding of implant surfaces the flap was sutured by 4-0 vicryl. After the operation, for antimicrobial treatment chlorhexidine was used for 10 days. The sutures were removed 10 days after the operation and post-operative controls were performed. The patients were invited to the followups in the first, third and sixth month after the operation. Clinical and radiographic measurements were repeated every six months
- Conditions
- Peri-Implantitis, Periodontal Diseases
- Being tested
- Periodontal surgery
- Medical subject headings
- Peri-Implantitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal surgeryProcedure or surgery
A total of forty dental implants were debrided with either ultrasonic instruments (test, n=20) or plastic scaler (control, n=20). Gingival recession depth (RD), keratinized tissue width (KTW), probing depth (PD), Gingival Index (GI) were evaluated at baseline and after 6 months. CBCT radiographs were used to evaluate peri-implant bone loss. Supportive and nonsurgical periodontal therapies were firstly consulted to reduce the inflammation, occurring due to the surgical treatments of the defects. The formation of bacterial biofilm on implant surfaces was removed by ultrasonic scaler and air polishing
| Study group | Role | What they receive |
|---|---|---|
| debridement made by ultrasonic tips | Experimental | mechanical debridement made by ultrasonic polyetheretherketone coated tips developed for implant surface and combined air-flow debridement Receives: Procedure: Periodontal surgery |
| implants were debrided with standard plastic curettes | Active comparator | dental implants were debrided with standard plastic curettes, debridement made by combined klorhegsidin rinse Receives: Procedure: Periodontal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment results
It was found in the study that the combined air-flow debridement and the mechanical debridement performed by using ultrasonic polyetheretherketone-coated tips developed for implant surface debridement in peri-implantitis therapy were better at decreasing the level of periodontal pocket depth than plastic curettes
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start23 Apr 2014
- Primary completion20 Nov 2016
- Study completion22 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ELİF ONCU, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241953
- Sponsor's protocol ID
- 2014-08
- Status last verified
- Aug 2017
- First submitted
- 3 Aug 2017
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISION OF DIFFERENT TREATMENT METHODS OF PERI-IMPLANTITIS
- ClinicalTrials.gov ID
- NCT03241953
- Acronym / sponsor ID
- 2014-08
- Conditions
- Peri-Implantitis, Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 23 Apr 2014 (actual)
- Primary completion
- 20 Nov 2016 (actual)
- Study completion
- 22 Dec 2016 (actual)
- First posted
- 8 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomized, controlled study, 18 patients with peri-implantitis were included. A total of forty dental implants were debrided with either ultrasonic instruments (test, n=20) or plastic scaler (control, n=20). Gingival recession depth (RD), keratinized tissue width (KTW), probing depth (PD), Gingival Index (GI) were evaluated at baseline and after 6 months. CBCT radiographs were used to evaluate peri-implant bone loss. Supportive and nonsurgical periodontal therapies were firstly consulted to reduce the inflammation, occurring due to the surgical treatments of the defects. The formation of bacterial biofilm on implant surfaces was removed by ultrasonic scaler and air polishing using abrasive powders or conventional plastic scaler with klorhegsidin combination.
Detailed description
Subject selection 18 systemically healthy patients, who applied to the Department of Periodontology, Necmettin Erbakan University and whose at least 1 dental implant was diagnosed by peri-implantitis and who has never taken peri-implantitis therapy, were included in the study. All patients were informed about the study and given informed consent form, and only volunteers were included. The research was conducted in accordance with the principles outlined in the Declaration of Helsinki. This prospective clinical study was approved by the Research Ethics Committee of Necmettin Erbakan University.
The patients, who were systemically and periodontally healthy and free of parafunctional habits like bruxism, and didn't have any kind of periodontal therapy within the previous year and had implants for at least 5 years, were included in the study. In addition, the inclusion criteria were as follows: having pocket depth over 5mm in implants diagnosed by peri-implantitis (Figure 1), having no mobility, having bone loss in implant site that is needed for augmentation(Figure 2). The patients with chronic bronchitis or asthma and major systemic illnesses (i.e. diabetes mellitus, cancer, HIV, bone metabolic diseases or disorders that compromise wound healing, radiation or immunosuppressive therapy) and those who had taken antibiotics, anti-inflammatory drugs or other medication within the previous 28 days were excluded in the study.
18 patients (mean age 52 years) diagnosed by peri- implantitis were included in this randomized and controlled study. A total of forty dental implants were debrided with either standard plastic curettes, debridement made by combined klorhegsidin rinse(control, n=20) or mechanical debridement made by ultrasonic polyetheretherketone coated tips developed for implant surface and combined air-flow debridement (test, n=20).
Clinical Measurements The clinical parameters given below were observed on six sites of all implants: Plaque Index (PlI; Silness \& Lo€e 1964), PD, Bleeding upon Probing (BOP) and Gingival Recession (RD; gingival margin location measuremant cemento- enamel junction to Gingival marjin).
On six sites of all implants, the following clinical parameters were recorded: Plaque Index (PlI; Silness \& Lo€e 1964), PD, Bleeding on Probing (BOP) and Gingival Recession (RD; gingival margin location measuremant cemento- enamel junction to Gingival marjin).
Keratinized tissue width (KTW) was measured at buccal midpoint of implants. Bone loss volume was recorded on con-beam computed tomographs (CBCT) by measuring the distance from bone implant abutment placement to alveolar bone level. All measurements were taken at the beginning. As we didn't perform any regenerative operations and didn't want the patients to be subjected to X-rays again, no more tomographs were taken.
Phase I Periodontal Therapy Upon the recordings, all patients were given Phase 1 periodontal therapy and informed about hygiene control. Prior to surgical operation, professional supragingival and subgingival debridement was performed during 2 or 4 appointments. The patients with a good level of oral hygiene were included in the study. Oral hygiene controls were performed in the first, third and sixth months prior to and after operations. Occlusion controls of all implant supported dental prosthesis were performed, and if present, extreme contacts were removed.
Phase II Periodontal Therapy 4 weeks after the initial periodontal treatments, for the treatment of the sites with pocket depth deeper than 5mm, flap operation was performed to achieve a direct reach to implant surfaces. Around affected implants, intrasulcular incisions were performed and mucoperiostal flaps with full thickness were raised both buccally and palatally. Implant surface decontamination is performed using with either plastic curettes or ultrasonic scaler (Figure 3); In control group, plastic curettes (Hue-Friedy Co., Chicago, IL, USA) were used for debridement and implant surfaces were decontaminated by klorhegsidin solution. In test group, sub-gingival operations with ultrasonic scaler was for nearly 20s per site (EMS Master Piezon LED, implant care system, Nyon, Switzerland). A special design disposable thermoplastic elastomer nozzle (Perio-flow Nozzle EMS Electro Medical Systems, Nyon, Sweden.), which horizontally gives out the glycine powder, was utilized.
The hand-device (Air-Flows EL-308/A; EMS Electro Medical Systems, Nyon, Sweden) was used in a circular motion, from coronal to apical, parallel to the implant surface in a noncontact mode. The operation period time at each aspect (i.e. mesial, distal, vestibular and oral) was limited to 5 s, as suggested by the manufacturer 35. The nozzle was moved with a circumferential movement around the implant to cover the entire exposed implant surface (36).
After the debriding of implant surfaces the flap was sutured by 4-0 vicryl. After the operation, for antimicrobial treatment chlorhexidine was used for 10 days. The sutures were removed 10 days after the operation and post-operative controls were performed. The patients were invited to the followups in the first, third and sixth month after the operation. Clinical and radiographic measurements were repeated every six months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| debridement made by ultrasonic tips | Experimental | Procedure: Periodontal surgerymechanical debridement made by ultrasonic polyetheretherketone coated tips developed for implant surface and combined air-flow debridement |
| implants were debrided with standard plastic curettes | Active comparator | Procedure: Periodontal surgerydental implants were debrided with standard plastic curettes, debridement made by combined klorhegsidin rinse |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients, who were systemically and periodontally healthy and free of parafunctional habits like bruxism, and didn't have any kind of periodontal therapy within the previous year and had implants for at least 5 years, were included in the study.
Key exclusion criteria (1 listed)
- The patients with chronic bronchitis or asthma and major systemic illnesses (i.e. diabetes mellitus, cancer, HIV, bone metabolic diseases or disorders that compromise wound healing, radiation or immunosuppressive therapy) and those who had taken antibiotics, anti-inflammatory drugs or other medication within the previous 28 days were excluded in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal surgeryA total of forty dental implants were debrided with either ultrasonic instruments (test, n=20) or plastic scaler (control, n=20). Gingival recession depth (RD), keratinized tissue width (KTW), probing depth (PD), Gingival Index (GI) were evaluated at baseline and after 6 months. CBCT radiographs were used to evaluate peri-implant bone loss. Supportive and nonsurgical periodontal therapies were firstly consulted to reduce the inflammation, occurring due to the surgical treatments of the defects. The formation of bacterial biofilm on implant surfaces was removed by ultrasonic scaler and air polishing | Procedure or surgery | debridement made by ultrasonic tips, implants were debrided with standard plastic curettes |
Primary outcome
Treatment results
Time frame: one year
It was found in the study that the combined air-flow debridement and the mechanical debridement performed by using ultrasonic polyetheretherketone-coated tips developed for implant surface debridement in peri-implantitis therapy were better at decreasing the level of periodontal pocket depth than plastic curettes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal surgery in people with Peri-Implantitis and Periodontal Diseases, run by Necmettin Erbakan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment results (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.