Intrabony Periodontal DefectsNCT02810054
Using MIST With or Without EMD in Treatment of Intrabony Periodontal Defects.
A study testing Minimally Invasive Surgical Techniques (MIST) and Enamel Matrix Derivative (EMD) in people with Intrabony Periodontal Defects, run by University of Manchester.
Trial summary
After performing the power calculation, healthy adult participants for the study will be randomly allocated into two groups. The intervention group will receive minimally invasive surgical techniques (MIST) with enamel matrix derivative (Emdogain) as a treatment of intrabony periodontal defect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrabony Periodontal Defects
- What is being tested?
- Minimally Invasive Surgical Techniques (MIST) and Enamel Matrix Derivative (EMD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Aug 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidate from both gender males and females with moderate to advanced periodontal disease.
- 18 years old and more.
- Probing pocket depth (PPD) of > 5mm and clinical attachment loss (CAL) of >6mm.
- 2 and 3-wall angular intra bony periodontal defects.
- Full-mouth plaque score (FMPS) of < 20%.
- Full-mouth bleeding score (FMBS) of < 15%.
- Medically fit and healthy.
- Not allergic to any materials or medications that could be used during or after the procedure.
Who cannot join
- Patients with diabetes and any haematological disorders that might compromise the procedure.
- 1-wall and crater defects.
- Immunocompromised patients and those with known allergy to one of the materials or medications to be used.
- Patients whose FMPS > 20%.
- Smokers.
- Pregnant women.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Periodontal Minimally Invasive Surgical Techniques With or Without Enamel Matrix Derivative Gel for Treatment of Intrabony Periodontal Osseous Defects in Humans.
After performing the power calculation, healthy adult participants for the study will be randomly allocated into two groups. The intervention group will receive minimally invasive surgical techniques (MIST) with enamel matrix derivative (Emdogain) as a treatment of intrabony periodontal defect. The control group will receive minimally invasive surgical techniques (MIST) without enamel matrix derivative (Emdogain).
Clinical attachment level (CAL) gain and periodontal pocket depth (PPD) reduction as well as the position of gingival margin (REC) as the main outcomes and the radiographic intrabony infill, bleeding on probing (BoP), full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) as secondary outcome will be recorded for the participants by 3 examiners at three stages:
Read more
- Before the procedure as a baseline record.
- 6 months after surgery, all parameters EXCEPT intra oral periapical (PA) radiographs.
- 12 months after surgery.
The readings will be recorded using The University of Michigan O Probe with William's Calibration OR Pressure Sensitive Periodontal Probe at 0.3 N to the nearest millimeter for the clinical attachment level gain (CAL), the periodontal pocket depth (PPD) and the position of gingival margin (REC), present or absent for the bleeding on probing (BoP), and intra oral periapical (PA) radiograph for crestal bone level assessment.
Read the detailed description
The surgical procedure appointment will take probably 45-75 minutes. The procedures will take the following steps:
- One Intra-oral periapical radiograph/X-ray should have been taken before the procedure and another one at month 12.
- Providing local anesthetics to numb the area to be worked on and it is just for selected sites and no need for general anesthesia at all.
- Using micro surgical blade to cut the gum very conservatively, as we will be using a very conservative minimally invasive surgical technique up-to-date.
- After establishing the visibility to the defective site with help of dental loups as a part of the procedure, we will clean the whole area using manual and ultrasonic cleaning instrument and making sure that there is no granulation (infected/inflamed) tissue inside the defect and the root surfaces of the affected tooth/teeth are very smooth.
- In case of using enamel matrix derivative gel (Emdogain) we will apply the material as the manufacturer recommends, while in the case of not using the enamel matrix derivative gel (Emdogain) we will do the standard open flap debridement (OFD) scaling and root planning for the affected sites and then closing and securing the flap/wound with exactly the same minimally invasive surgical technique.
- According to the technique to be used we will use the suitable type of suture material and technique to make sure that the flap/wound is closed in place and secured properly.
- At the end of the procedure the patient will receive post-operative instructions which are a kind of Do's \& Don't as follow:
- Don't clean the wound for the next 2 weeks. B. Using chlorhexidine based mouth wash 0.12% twice a day for 3 weeks. C. Don't eat or drink hot food and drinks for the first 2 days, after that you may start using warm food and back to normal in a week time.
- Don't play or disturb the suture with your tongue, lips or fingers. D. Try not to do exercises during the 1st week. E. Do brush the rest of your teeth.
- The participant will be asked to attend a 15 minutes appointment 7-10 days right after the procedure for suture removal. Then every two weeks until month 3 just for evaluation of healing and performing any kind of treatment that might be needed for example; superficial cleaning. Then you will be asked to attend one appointment a month until month 6 to take the measurements again and providing any cleaning needed, then at month 9, and finally, at month 12 to take the measurements for the last time to compare them with the baseline measurement.
- Conditions
- Intrabony Periodontal Defects
- Being tested
- Minimally Invasive Surgical Techniques (MIST), Enamel Matrix Derivative (EMD)
- Keywords
- regeneration, intrabony defects, enamel matrix derivative, MIST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Surgical Techniques (MIST)Procedure or surgery
Using minimally invasive surgical techniques.
Enamel Matrix Derivative (EMD)Procedure or surgery
Use of enamel matrix derivative for the treatment of intrabony periodontal defects.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (MIST without EMD) | Sham comparator | Those participants who will receive the minimally invasive surgical techniques but without application Enamel Matrix Derivative (EMD) . Receives: Procedure: Minimally Invasive Surgical Techniques (MIST) |
| Test Group (MIST with EMD) | Experimental | Those participant who will receive the minimally invasive surgical techniques with the application of Enamel Matrix Derivative (EMD) . Receives: Procedure: Minimally Invasive Surgical Techniques (MIST); Procedure: Enamel Matrix Derivative (EMD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical attachment level gain CAL
periodontal clinical attachment level gain
Measured: 12 months
Secondary outcomes (5)
radiographic bone fill
assessing the bone level from the cemento-enamel junction to the crestal bone height
Measured: 12 months
full mouth bleeding score FMBS
Measured: 12 months
full mouth dental plaque score FMPS
Measured: 12 months
periodontal probing depth reduction PPD
Measured: 12 months
marginal gingival recession REC
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrabony Periodontal DefectsStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muataz Osman, University of Manchester
- Investigators
- Kevin G Seymour, Study director, The University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810054
- Sponsor's protocol ID
- MSCPERIO-001
- Status last verified
- Jun 2016
- First submitted
- 20 Jun 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual Participant data will not be shared however once anonymised the results may be published.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Minimally Invasive Surgical Techniques With or Without Enamel Matrix Derivative Gel for Treatment of Intrabony Periodontal Osseous Defects in Humans.
- ClinicalTrials.gov ID
- NCT02810054
- Acronym / sponsor ID
- MSCPERIO-001
- Conditions
- Intrabony Periodontal Defects
- Keywords
- regeneration, intrabony defects, enamel matrix derivative, MIST
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 22 Jun 2016 (estimated)
- 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.
After performing the power calculation, healthy adult participants for the study will be randomly allocated into two groups. The intervention group will receive minimally invasive surgical techniques (MIST) with enamel matrix derivative (Emdogain) as a treatment of intrabony periodontal defect. The control group will receive minimally invasive surgical techniques (MIST) without enamel matrix derivative (Emdogain).
Clinical attachment level (CAL) gain and periodontal pocket depth (PPD) reduction as well as the position of gingival margin (REC) as the main outcomes and the radiographic intrabony infill, bleeding on probing (BoP), full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) as secondary outcome will be recorded for the participants by 3 examiners at three stages:
- Before the procedure as a baseline record.
- 6 months after surgery, all parameters EXCEPT intra oral periapical (PA) radiographs.
- 12 months after surgery.
The readings will be recorded using The University of Michigan O Probe with William's Calibration OR Pressure Sensitive Periodontal Probe at 0.3 N to the nearest millimeter for the clinical attachment level gain (CAL), the periodontal pocket depth (PPD) and the position of gingival margin (REC), present or absent for the bleeding on probing (BoP), and intra oral periapical (PA) radiograph for crestal bone level assessment.
Detailed description
The surgical procedure appointment will take probably 45-75 minutes. The procedures will take the following steps:
- One Intra-oral periapical radiograph/X-ray should have been taken before the procedure and another one at month 12.
- Providing local anesthetics to numb the area to be worked on and it is just for selected sites and no need for general anesthesia at all.
- Using micro surgical blade to cut the gum very conservatively, as we will be using a very conservative minimally invasive surgical technique up-to-date.
- After establishing the visibility to the defective site with help of dental loups as a part of the procedure, we will clean the whole area using manual and ultrasonic cleaning instrument and making sure that there is no granulation (infected/inflamed) tissue inside the defect and the root surfaces of the affected tooth/teeth are very smooth.
- In case of using enamel matrix derivative gel (Emdogain) we will apply the material as the manufacturer recommends, while in the case of not using the enamel matrix derivative gel (Emdogain) we will do the standard open flap debridement (OFD) scaling and root planning for the affected sites and then closing and securing the flap/wound with exactly the same minimally invasive surgical technique.
- According to the technique to be used we will use the suitable type of suture material and technique to make sure that the flap/wound is closed in place and secured properly.
- At the end of the procedure the patient will receive post-operative instructions which are a kind of Do's \& Don't as follow:
- Don't clean the wound for the next 2 weeks. B. Using chlorhexidine based mouth wash 0.12% twice a day for 3 weeks. C. Don't eat or drink hot food and drinks for the first 2 days, after that you may start using warm food and back to normal in a week time.
- Don't play or disturb the suture with your tongue, lips or fingers. D. Try not to do exercises during the 1st week. E. Do brush the rest of your teeth.
- The participant will be asked to attend a 15 minutes appointment 7-10 days right after the procedure for suture removal. Then every two weeks until month 3 just for evaluation of healing and performing any kind of treatment that might be needed for example; superficial cleaning. Then you will be asked to attend one appointment a month until month 6 to take the measurements again and providing any cleaning needed, then at month 9, and finally, at month 12 to take the measurements for the last time to compare them with the baseline measurement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (MIST without EMD) | Sham comparator | Procedure: Minimally Invasive Surgical Techniques (MIST)Those participants who will receive the minimally invasive surgical techniques but without application Enamel Matrix Derivative (EMD) . |
| Test Group (MIST with EMD) | Experimental | Procedure: Minimally Invasive Surgical Techniques (MIST), Procedure: Enamel Matrix Derivative (EMD)Those participant who will receive the minimally invasive surgical techniques with the application of Enamel Matrix Derivative (EMD) . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Candidate from both gender males and females with moderate to advanced periodontal disease.
- 18 years old and more.
- Probing pocket depth (PPD) of > 5mm and clinical attachment loss (CAL) of >6mm.
- 2 and 3-wall angular intra bony periodontal defects.
- Full-mouth plaque score (FMPS) of < 20%.
Key exclusion criteria (6 listed)
- Patients with diabetes and any haematological disorders that might compromise the procedure.
- 1-wall and crater defects.
- Immunocompromised patients and those with known allergy to one of the materials or medications to be used.
- Patients whose FMPS > 20%.
- Smokers.
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 |
|---|---|---|
| Minimally Invasive Surgical Techniques (MIST)Using minimally invasive surgical techniques. | Procedure or surgery | Control Group (MIST without EMD), Test Group (MIST with EMD) |
| Enamel Matrix Derivative (EMD)Use of enamel matrix derivative for the treatment of intrabony periodontal defects. | Procedure or surgery | Test Group (MIST with EMD) |
Primary outcome
clinical attachment level gain CAL
Time frame: 12 months
periodontal clinical attachment level gain
5 secondary outcomes
radiographic bone fill
Time frame: 12 months
full mouth bleeding score FMBS
Time frame: 12 months
full mouth dental plaque score FMPS
Time frame: 12 months
periodontal probing depth reduction PPD
Time frame: 12 months
marginal gingival recession REC
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Individual participant dataSharing planned: No. Individual Participant data will not be shared however once anonymised the results may be published.
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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.
Kevin G Seymour study director
The University of Manchester
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Surgical Techniques (MIST) and Enamel Matrix Derivative (EMD) in people with Intrabony Periodontal Defects, run by University of Manchester.
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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Jun 2016. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin G Seymour (+44 (0) 161 306 1578, kevin.seymour@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical attachment level gain CAL (time frame: 12 months). 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 28 Jun 2016.