Using MIST With or Without EMD in Treatment of Intrabony Periodontal Defects.

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:

1. Before the procedure as a baseline record.
2. 6 months after surgery, all parameters EXCEPT intra oral periapical (PA) radiographs.
3. 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.

Study Overview

• Status: Unknown
• Conditions: Intrabony Periodontal Defects
• Intervention / Treatment: Procedure: Minimally Invasive Surgical Techniques (MIST); Procedure: Enamel Matrix Derivative (EMD)

Detailed Description

The surgical procedure appointment will take probably 45-75 minutes. The procedures will take the following steps:

1. One Intra-oral periapical radiograph/X-ray should have been taken before the procedure and another one at month 12.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

7. At the end of the procedure the patient will receive post-operative instructions which are a kind of Do's & Don't as follow:

   A. 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.

   C. 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.

8. 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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Candidate from both gender males and females with moderate to advanced periodontal disease.
2. 18 years old and more.
3. Probing pocket depth (PPD) of > 5mm and clinical attachment loss (CAL) of >6mm.
4. 2 and 3-wall angular intra bony periodontal defects.
5. Full-mouth plaque score (FMPS) of < 20%.
6. Full-mouth bleeding score (FMBS) of < 15%.
7. Medically fit and healthy.
8. Not allergic to any materials or medications that could be used during or after the procedure.

Exclusion Criteria:

1. Patients with diabetes and any haematological disorders that might compromise the procedure.
2. 1-wall and crater defects.
3. Immunocompromised patients and those with known allergy to one of the materials or medications to be used.
4. Patients whose FMPS > 20%.
5. Smokers.
6. Pregnant women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Control Group (MIST without EMD); Those participants who will receive the minimally invasive surgical techniques but without application Enamel Matrix Derivative (EMD) .	Procedure: Minimally Invasive Surgical Techniques (MIST); Using minimally invasive surgical techniques.
EXPERIMENTAL: Test Group (MIST with EMD); Those participant who will receive the minimally invasive surgical techniques with the application of Enamel Matrix Derivative (EMD) .	Procedure: Minimally Invasive Surgical Techniques (MIST); Using minimally invasive surgical techniques.; Procedure: Enamel Matrix Derivative (EMD); Use of enamel matrix derivative for the treatment of intrabony periodontal defects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical attachment level gain CAL	periodontal clinical attachment level gain	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiographic bone fill	assessing the bone level from the cemento-enamel junction to the crestal bone height	12 months
full mouth bleeding score FMBS		12 months
full mouth dental plaque score FMPS		12 months
periodontal probing depth reduction PPD		12 months
marginal gingival recession REC		12 months

Collaborators and Investigators

• Sponsor: University of Manchester
• Investigators: Study Director: Kevin G Seymour, The University of Manchester

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (ANTICIPATED): July 1, 2018
• Study Completion (ANTICIPATED): August 1, 2018

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (ESTIMATE): June 22, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 28, 2016
• Last Update Submitted That Met QC Criteria: June 27, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: regeneration; enamel matrix derivative; MIST; intrabony defects
• Other Study ID Numbers: MSCPERIO-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant data will not be shared however once anonymised the results may be published.