PeriodontitisNCT02551770
Emdogain Minimally Invasive Surgical Technique
A study testing Scaling and root planing, Scaling and root planing without Emdogain and Emdogain application in people with Periodontitis, run by Institut Straumann AG at 4 sites in 3 countries.
Trial summary
The aim of this controlled study is to assess the clinical outcomes and patient reported outcomes of using minimally invasive surgical procedure with Straumann Emdogain as an adjunct (test treatment) or without Straumann Emdogain (control treatment). Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Scaling and root planing, Scaling and root planing without Emdogain and Emdogain application
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Oct 2015to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must have voluntarily signed the informed consent form before any study related procedures
- Subjects must be males or females who are 18-85 years of age
- Subjects must have moderate to severe chronic, generalized periodontitis with pockets of 5 mm - 8mm probing depth in at least 2 pockets per contralateral quadrants in one arch (study teeth)
- Subjects must be committed to the study and the required follow-up visits
- Subjects must be in good general health as assessed by the Investigator
Who cannot join
- Subjects taking or intending to take any medications during the duration of the study that will potentially affect healing and inflammation
- Subjects who are currently heavy smokers (defined >10 cigarettes per day or >1 cigar per day) or who use chewing tobacco
- Subjects being treated with systemic antibiotics or subjects that were treated with systemic antibiotics within 3 months prior to treatment in this study
- Subjects with uncontrolled diabetes
- Subjects that are immunocompromised or immunosuppressed
- Subjects that cannot provide informed consent
Show all 16Show fewer
- Subjects with drug or alcohol abuse
- Subjects that have undergone periodontal root planing or periodontal surgery in the last 6 months
- Subjects that are pregnant
- Subjects with necrotizing periodontitis or periodontitis related to systemic disease
- Teeth with pockets with probing depth ≥ 9 mm will not classify as study teeth
- Teeth with pockets or defects with furcation involvement will not classify as study teeth
- Teeth with mobility degree > 1 without splint will not classify as study teeth
- Subjects with test and control sites in the two quadrants on adjacent teeth
- Patients with compromised health conditions such as diabetes, systemic diseases, high dose steroid therapy, bone metabolic diseases, radiation or immune-oppressive therapy, and infections or vascular impairment at the surgical site
- Subjects with conditions or circumstances, in the opinion of the Investigator , which would prevent completion of study participation or interfere with analysis of study results
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Periodontics and Implant Dentistry
Aurora, Colorado, 80012-3202
Periodontal and Implant Associates, Inc.
Cullman, Alabama, 35055
Germany1 site
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz, 55131
About this study
Official title: Straumann® Emdogain® Application In Conjunction With Minimally Invasive Surgical Technique For Periodontal Disease Treatment: A Split-Mouth Design Study
The aim of this controlled study is to assess the clinical outcomes and patient reported outcomes of using minimally invasive surgical procedure with Straumann Emdogain as an adjunct (test treatment) or without Straumann Emdogain (control treatment).
Read the detailed description
The aim of the study will be achieved through the following primary and secondary objectives. The primary objective is to evaluate the regenerative potential of Straumann Emdogain by comparing the change in clinical attachment level from baseline to 12 months between the test and control arms. The regenerative potential of Straumann Emdogain will also be assessed by comparing the changes in gingival margins, changes in average probing pocket depth, changes in full mouth plaque score, changes in bleeding on probing, and changes in root dentin hypersensitivity from baseline to 12 months between the test and control arms.
- Conditions
- Periodontitis
- Being tested
- Scaling and root planing, Scaling and root planing without Emdogain, Emdogain application
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planingProcedure or surgery
Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw.
Scaling and root planing without EmdogainProcedure or surgery
Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw.
Emdogain applicationDevice
Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw
| Study group | Role | What they receive |
|---|---|---|
| Test (with Emdogain) | Active comparator | Scaling and root planing with Emdogain Receives: Procedure: Scaling and root planing; Device: Emdogain application |
| Control (without Emdogain) | Other | Scaling and root planing without Emdogain Receives: Procedure: Scaling and root planing without Emdogain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Attachment Levels (CAL)
CAL will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of CAL from baseline measurements at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of CAL for test and control treatment arms.
Measured: Baseline and 12 Month Follow-Up Visit
Secondary outcomes (6)
Change in Gingival Margin (GM)
GM will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of GM from baseline at surgery to 12-months-post surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of GM for test and control treatment arms.
Measured: Baseline and 12 Month Follow-Up Visit
Change in Pocket Probing Depth (PPD)
PPD will be measured in millimeters on the study teeth in 6 locations. Outcome is mean change of PPD from baseline at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth at baseline. Analysis will compare the mean change of PPD for test and control treatment arms.
Measured: Baseline and 12 Month Follow-Up Visit
Change in Full Mouth Plaque Score (FMPS)
FMPS will be calculated based on the number of tooth surfaces with plaque over the total number of tooth surfaces x 100. The value is presented as a percent. The difference in FMPS between 12 months and baseline will be determined.
Measured: Baseline and 12 Month Follow-Up Visit
Change in Bleeding on Probing (BoP)
For the categorical variable BoP, the frequency of bleeding (present or absent) will be counted (absolute and in percent) over all measured sites around the identified study teeth for each treatment group. The results will be compared between the 12-month follow-up and baseline.
Measured: Baseline and 12 Month Follow-Up Visit
Change in Root Dentin Hypersensitivity
Presence of root dentin hypersensitivity will be recorded as "none" (no reaction from the subject), "mild" (sensible with no pain), "moderate" (sensible with slight pain), or "severe" (sensible with pain that persists for a while) after a conventional air blast is applied to the study tooth. Changes in the frequency of categories will be determined and compared between the two treatment arms. An improvement is defined as a decreased reaction (for example, severe to mild), a deterioration is defined as increased reaction (for example, none to moderate), and unchanged is no change to reaction (for example, mild to mild).
Measured: Baseline and 12 Month Follow-Up Visit
Change in Post-surgical Pain
Post-surgical pain will be measured on a 100 millimeter visual analog scale. The range is 0 (no pain) to 99 (nearly maximum pain). The lower the value, the better the outcome. The subjects will be instructed to mark their level of pain on a line for both the test quadrant and the control quadrant. The average change in pain level will be determined and compared between the two arms.
Measured: 1-2 days post surgery, 1 week post surgery, and 2 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2018
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Straumann AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela K McClain, DDS, Principal investigator, Periodontics and Implant DentistryVeronique Benhamou, DDS, Principal investigator, Clinique Paro ExcellenceJennifer H Doobrow, DMD, Principal investigator, Periodontal & Implant Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551770
- Sponsor's protocol ID
- CR 01/15
- Status last verified
- Oct 2019
- First submitted
- 14 Sep 2015
- Last updated
- 17 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Straumann® Emdogain® Application In Conjunction With Minimally Invasive Surgical Technique For Periodontal Disease Treatment: A Split-Mouth Design Study
- ClinicalTrials.gov ID
- NCT02551770
- Acronym / sponsor ID
- CR 01/15
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Institut Straumann AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Posted 17 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this controlled study is to assess the clinical outcomes and patient reported outcomes of using minimally invasive surgical procedure with Straumann Emdogain as an adjunct (test treatment) or without Straumann Emdogain (control treatment).
Detailed description
The aim of the study will be achieved through the following primary and secondary objectives. The primary objective is to evaluate the regenerative potential of Straumann Emdogain by comparing the change in clinical attachment level from baseline to 12 months between the test and control arms. The regenerative potential of Straumann Emdogain will also be assessed by comparing the changes in gingival margins, changes in average probing pocket depth, changes in full mouth plaque score, changes in bleeding on probing, and changes in root dentin hypersensitivity from baseline to 12 months between the test and control arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test (with Emdogain) | Active comparator | Procedure: Scaling and root planing, Device: Emdogain applicationScaling and root planing with Emdogain |
| Control (without Emdogain) | Other | Procedure: Scaling and root planing without EmdogainScaling and root planing without Emdogain |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must have voluntarily signed the informed consent form before any study related procedures
- Subjects must be males or females who are 18-85 years of age
- Subjects must have moderate to severe chronic, generalized periodontitis with pockets of 5 mm - 8mm probing depth in at least 2 pockets per contralateral quadrants in one arch (study teeth)
- Subjects must be committed to the study and the required follow-up visits
- Subjects must be in good general health as assessed by the Investigator
Key exclusion criteria (16 listed)
- Subjects taking or intending to take any medications during the duration of the study that will potentially affect healing and inflammation
- Subjects who are currently heavy smokers (defined >10 cigarettes per day or >1 cigar per day) or who use chewing tobacco
- Subjects being treated with systemic antibiotics or subjects that were treated with systemic antibiotics within 3 months prior to treatment in this study
- Subjects with uncontrolled diabetes
- Subjects that are immunocompromised or immunosuppressed
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 |
|---|---|---|
| Scaling and root planingUsing minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw. | Procedure or surgery | Test (with Emdogain) |
| Scaling and root planing without EmdogainUsing minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw. | Procedure or surgery | Control (without Emdogain) |
| Emdogain applicationUsing minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw | Device | Test (with Emdogain) |
Primary outcome
Change in Clinical Attachment Levels (CAL)
Time frame: Baseline and 12 Month Follow-Up Visit
CAL will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of CAL from baseline measurements at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of CAL for test and control treatment arms.
6 secondary outcomes
Change in Gingival Margin (GM)
Time frame: Baseline and 12 Month Follow-Up Visit
Change in Pocket Probing Depth (PPD)
Time frame: Baseline and 12 Month Follow-Up Visit
Change in Full Mouth Plaque Score (FMPS)
Time frame: Baseline and 12 Month Follow-Up Visit
Change in Bleeding on Probing (BoP)
Time frame: Baseline and 12 Month Follow-Up Visit
Change in Root Dentin Hypersensitivity
Time frame: Baseline and 12 Month Follow-Up Visit
Change in Post-surgical Pain
Time frame: 1-2 days post surgery, 1 week post surgery, and 2 weeks post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Pamela K McClain, DDS principal investigator
Periodontics and Implant Dentistry
Veronique Benhamou, DDS principal investigator
Clinique Paro Excellence
Jennifer H Doobrow, DMD principal investigator
Periodontal & Implant Associates
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing, Scaling and root planing without Emdogain and Emdogain application in people with Periodontitis, run by Institut Straumann AG at 4 sites in 3 countries.
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 5 inclusion and 16 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 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 17 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Clinical Attachment Levels (CAL) (time frame: Baseline and 12 Month Follow-Up Visit). 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 17 Oct 2019.