|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT03163654 |
|
Date of registration:
|
21/05/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Novel Porcine Dermal Matrix in the Treatment of Multiple Adjacent Gingival Recessions
NPDMMAGR |
|
Scientific title:
|
Novel Porcine Dermal Matrix Vs. Connective Tissue Graft in the Treatment of Multiple Adjacent Gingival Recessions of Miller Class I and II: a 12-month Randomized Controlled Clinical Trial |
|
Date of first enrolment:
|
December 2014 |
|
Target sample size:
|
16 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03163654 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Serbia
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. At least two multiple maxillaries or mandibular Miller's Class I and II recession,
more than >2mm defects together with similar contralateral lesions
2. No active periodontal disease with PD>4mm
3. Absence of the radiographic signs of periapical infection on the teeth to be treated
or on the adjacent teeth
4. A full mouth plaque index <20% and gingival index < 1
Exclusion Criteria:
1. The inflammatory periodontal disease/ Untreated periodontal conditions
2. Previous surgical attempt to correct gingival recession
3. Pregnant or breastfeeding women
4. Systemic diseases with compromised healing potential or infectious diseases
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Recession, Gingival
|
|
Intervention(s)
|
|
Procedure: Surgery 1
|
|
Procedure: Surgery 2
|
|
Primary Outcome(s)
|
|
complete root coverage (CRC)
[Time Frame: 12 months]
|
|
mean root coverage (MRC)
[Time Frame: 12 months]
|
|
Secondary Outcome(s)
|
|
gingival recession width (GRW)
[Time Frame: 12 months]
|
|
gingival recession (GR)
[Time Frame: 12 months]
|
|
Gingival thickness (GT)
[Time Frame: 12 months]
|
|
Keratinized tissue wide (KTW)
[Time Frame: 12 months]
|
|
Clinical attachment level (CAL),
[Time Frame: 12 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|