Enamel Matrix Derivative (EMDOGAIN) for the treatment of gum recession and dental implant infection/ridge management

Not Applicable

Completed

• Conditions: Gingival Recession; Peri-implantitis; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12619000062123
• Lead Sponsor: Dr. Faustino Mercado

Brief Summary

The addition of emdogain with gum graft resulted in better root coverage of gum recession and thicker gum in the lower anterior teeth when compared to gum graft alone. It also resulted in significantly less pain in the first 2 weeks after the surgery. The addition of emdogain with bone graft managed to control the peri-implantitis progression within the first 2 years after deep cleaning.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-12-10
• Study Start: 2019-01-17
• Last Update Posted: 28 January 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Systemically healthy stable/treated periodontal condition, non-smokers and aged between 18-70 years old, not pregnant or lactating, not taking any steroid medications, bisphosponates or anti-depressive medications.
Eligible participants will be allocated to one of the four above-mentioned treatment groups after an initial examination by a trained dental surgeon. A unique identifier number will be assigned to each participant at this time to provide confidentiality throughout the study.

Exclusion Criteria

Smokers, Patients with uncontrolled diabetes, those taking bisphosphonates, anti-depressants and antipsychotic medications, and pregnant or lactating females were excluded from the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recession measurement by mm using periodontal probe[The patients will be seen and gum measured every 6 months and the 12th month and 24th month measurements after treatment will be used for the analysis of the study.];Radiographic measurement of bone level before and after surgical treatments. [X-rays will be taken at the 12th and 24th month review after the surgeries. This two x-rays will be compare to the one taken before the treatments are performed.];pain level[1st and 2nd week after surgical treatment. The patient will be given a pain sheet after the treatment allotted. This pain sheet will be marked as a Visual analogue scale lined 1-10. The patient will put a vertical mark on a line marked 1-10 according to their degree of pain on the 2nd, 7th and 14th day after surgical treatments.These 3 pain scores will be analysed comparing Test and Control Groups.]

Secondary Outcome Measures

Name	Time	Method
Measurement of keratinized tissue - to be measured using periodontal probe every 6 months the patients are reviewed. The values measured on the 12th and 24th month will be analysed for the studies.[1st and 2nd year after surgical treatment];Bleeding gums[To be measured every 6 months of review using periodontal probe.];Tooth Retention[teeth to be counted on the 12th and 24th month of reviews];esthetic outcome[The patient will score 1-10, 1 worst to 10 best aesthetic scores around the surgical area graded on the 12th and 24th month of reviews]