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

NCT02810054 | Unknown

• 1 other identifier: MSCPERIO-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 1.Before the procedure as a baseline record.
2. 2.6 months after surgery, all parameters EXCEPT intra oral periapical (PA) radiographs.
3. 3.12 months after surgery.

Conditions

Intrabony Periodontal Defects

Keywords

regeneration; intrabony defects; enamel matrix derivative; MIST

Outcome Measures

Primary Outcomes (1)

• clinical attachment level gain CAL

  periodontal clinical attachment level gain

  12 months

Secondary Outcomes (5)

• radiographic bone fill

  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

Study Arms (2)

Control Group (MIST without EMD)

SHAM COMPARATOR

Those participants who will receive the minimally invasive surgical techniques but without application Enamel Matrix Derivative (EMD) .

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) .

Procedure: Minimally Invasive Surgical Techniques (MIST); Procedure: Enamel Matrix Derivative (EMD)

Interventions

Minimally Invasive Surgical Techniques (MIST) PROCEDURE

Using minimally invasive surgical techniques.

Control Group (MIST without EMD); Test Group (MIST with EMD)

Enamel Matrix Derivative (EMD) PROCEDURE

Use of enamel matrix derivative for the treatment of intrabony periodontal defects.

Test Group (MIST with EMD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidate from both gender males and females with moderate to advanced periodontal disease.
• years old and more.
• Probing pocket depth (PPD) of \> 5mm and clinical attachment loss (CAL) of \>6mm.
• 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.

You may not qualify if:

• Patients with diabetes and any haematological disorders that might compromise the procedure.
• 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.

Sponsors & Collaborators

• University of Manchester: lead

Study Officials

• Kevin G Seymour

  The University of Manchester

  STUDY DIRECTOR

Central Study Contacts

Kevin G Seymour

CONTACT

+44 (0) 161 306 1578; kevin.seymour@manchester.ac.uk

Hugo G Pinto

CONTACT

+44 (0)161 306 1566; hudo.pinto@manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 22, 2016
• Study Start: September 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: June 28, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share