Using Inverted Periosteal Pedicle Flap in Treatment of Gingival Recession
IPPF
Assessment of Postoperative Discomfort Following Inverted Periosteal Pedicle Flap Versus Coronally Advanced Flap With Subepithelial Connective Tissue Graft in Treatment of Gingival Recession Types 1 and 2. A Randomized Clinical Trial.
1 other identifier
interventional
18
1 country
1
Brief Summary
Perioteum in the recession defect site will be used as an autogenous graft after raising a flap and the results will be compared with another group which will be treated by the gold standard ( coronally advanced flap with subepithelial connective tissue graft).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedStudy Start
First participant enrolled
January 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2020
CompletedJanuary 13, 2020
January 1, 2020
1 month
October 7, 2018
January 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-operative discomfort
Numerical using Visual analogue scale (VAS) Questionnaire
3 weeks
Secondary Outcomes (4)
Amount of root coverage
3 months and 6 months
Probing depth
3 months and 6 months
esthetics
6 months
patient's satisfaction
6 months
Study Arms (2)
Grpup A (Test group)
EXPERIMENTALInverted periosteal pedicle flap will be carried out
Group B (Control group)
ACTIVE COMPARATORCoronally advanced flap with subepithelial connective tissue graft
Interventions
The periosteum will be used as an autogenous graft after raising a partial thickness flap in group A
Eligibility Criteria
You may qualify if:
- Gender: Male and Female
- Age: \>20 years
- Have RT1 and RT2 gingival recession
You may not qualify if:
- Medically compromised
- History of certain medications
- Pregnant females
- Periapical involvement in selected teeth
- History of periodontal surgery involving experimental teeth
- If the problem was due to orthodontic treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marwa El Sayed Abbas Ahmedlead
- Cairo Universitycollaborator
Study Sites (1)
Cairo university, Faclty of dentistry
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Two outcome assessors will be chosen: one will be a periodontist but not included within the research; and the other will be a non-periodontist. The outcome assessors will be blinded; they will not be informed by the type of intervention to be assessed.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Lecturer
Study Record Dates
First Submitted
October 7, 2018
First Posted
October 9, 2018
Study Start
January 25, 2020
Primary Completion
February 28, 2020
Study Completion
August 28, 2020
Last Updated
January 13, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 1 year
publishing in an international journal