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

NCT02810054 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-06-28

No results posted yet for this study

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. 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.

Conditions

  • Intrabony Periodontal Defects

Interventions

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.

Sponsors & Collaborators

  • University of Manchester

    lead OTHER

Principal Investigators

  • Kevin G Seymour · The University of Manchester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-07-31
Completion
2018-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02810054 on ClinicalTrials.gov