Using Inverted Periosteal Pedicle Flap in Treatment of Gingival Recession (IPPF)
Primary Purpose
Gingival Recession
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Inverted periosteal pedicle flap
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring gingival recession, periosteum, autogenous graft
Eligibility Criteria
Inclusion Criteria:
- Gender: Male and Female
- Age: >20 years
- Have RT1 and RT2 gingival recession
Exclusion Criteria:
- 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
Sites / Locations
- Cairo university, Faclty of dentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Grpup A (Test group)
Group B (Control group)
Arm Description
Inverted periosteal pedicle flap will be carried out
Coronally advanced flap with subepithelial connective tissue graft
Outcomes
Primary Outcome Measures
Post-operative discomfort
Numerical using Visual analogue scale (VAS) Questionnaire
Secondary Outcome Measures
Amount of root coverage
continuous (mm)
Probing depth
continuous (mm)
esthetics
numerical using Root coverage esthetic score (RES)
patient's satisfaction
categorical via assessment of patient-related criteria using a 3-point rating scale
Full Information
NCT ID
NCT03701191
First Posted
October 7, 2018
Last Updated
January 9, 2020
Sponsor
Marwa El Sayed Abbas Ahmed
Collaborators
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT03701191
Brief Title
Using Inverted Periosteal Pedicle Flap in Treatment of Gingival Recession
Acronym
IPPF
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2020 (Anticipated)
Primary Completion Date
February 28, 2020 (Anticipated)
Study Completion Date
August 28, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marwa El Sayed Abbas Ahmed
Collaborators
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
Eighteen participants will be recruited.
Included participants will be:
Gender: Male and Female
Age: >20 years
Have RT1 and RT2 gingival recession
Exclusion criteria:
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
11. Interventions: Participants will be divided into two groups, group A (test group) and group B ( control group).
Pre-surgical phase (including supragingival scaling and root planning) will be carried out to both groups, followed by oral hygiene instructions.
Then, Participants will be explained about each procedure. 7
For group A (test group):
Inverted periosteal pedicle flap will be carried out as follows according to Shetty 2014:
Patients will be explained about the procedure. Non-surgical phase will include supragingival scaling and root planning, followed by oral hygiene instructions.
The surgical procedure will be carried out three weeks after non-surgical phase as follows:
Horizontal incisions will be made perpendicular to the adjacent papillae at the level of the cement-enamel junction (CEJ) preserving the gingival margin of the affected teeth.
Sulcular incisions on the buccal/facial aspect of the involved teeth.
Vertical incisions extending beyond the mucogingival junction will be made at the line angles of the distal most and the mesial most teeth.
A partial thickness flap will then be elevated till an adequate amount of periosteum is exposed.
A horizontal incision will then be given at the apical extent of the periosteum where it is still attached to the bone.
The periosteum will then be separated from the underlying bone and reflected coronally to an extent where it is still attached to the bone.
The reflected periosteum will then be inverted such that the cambium layer covers the denuded root.
Once the periosteum is in place, it is sutured and secured.
The reflected partial thickness flap will be coronally advanced such that it covers the periosteum and will be sutured using a sling suture.
The vertical incision will be sutured using an interrupted suture. 8
For group B (control group):
Coronally advanced flap with subepithelial connective tissue graft will be carried out; an envelope flap design will be used according to Zucchelli & De Sanctis 2000 as follows:
An intrasulcular incision will be performed involving at least one tooth mesial and at least one tooth distal to the teeth with gingival recessions.
Oblique incisions will be traced at the interdental soft tissue level to achieve a coronal rotation of the surgical papilla.
The flap will be then raised up to the mucogingival junction (MGJ) with a periosteal elevator and mobilized with a sharp horizontal periosteal incision beyond the MGJ.
Exposed root surfaces will be carefully treated with gentle root planing.
The anatomic interdental papillae will be carefully de-epithelialized.
The split-full-split thickness flap will be then passively positioned above the CEJ of the involved teeth and interrupted or sling sutures were positioned to achieve optimal buccal flap adaptation.
The connective tissue graft will be harvested from the palate using the trap door technique (Langer & Langer 1985), adapted to cover each exposed root about 1 mm beyond the CEJ, and stabilized with resorbable sutures.
The flap will be then coronally sutured using sling or interrupted sutures.
Post-surgical protocol (Pini-Prato et al.,2010 and Cairo et al., 2016) :
Participants for both groups will be instructed to:
Intermittently apply an ice bag for the first 4 hours.
Take ibuprofen 600 mg at the end of the surgical procedure and will be instructed to take another tablet 6 h later and additional doses if needed.
Avoid any mechanical trauma and tooth-brushing for 3 weeks in the surgical area.
Smokers will be reminded to quit smoking during the trial time (6 months).
Chlorexidine rinses will be prescribed twice daily for 1 min. seven days after the surgery.
Sutures will be removed and prophylaxis will be performed. 9
About 3 weeks after surgery, patients will be instructed to resume mechanical tooth-cleaning.
Follow up strategy:
Patients will be recalled after 3and 6 months after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
gingival recession, periosteum, autogenous graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Included participants will be:
Gender: Male and Female
Age: >20 years
Have RT1 and RT2 gingival recession
Exclusion criteria:
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
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Grpup A (Test group)
Arm Type
Experimental
Arm Description
Inverted periosteal pedicle flap will be carried out
Arm Title
Group B (Control group)
Arm Type
Active Comparator
Arm Description
Coronally advanced flap with subepithelial connective tissue graft
Intervention Type
Procedure
Intervention Name(s)
Inverted periosteal pedicle flap
Intervention Description
The periosteum will be used as an autogenous graft after raising a partial thickness flap in group A
Primary Outcome Measure Information:
Title
Post-operative discomfort
Description
Numerical using Visual analogue scale (VAS) Questionnaire
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Amount of root coverage
Description
continuous (mm)
Time Frame
3 months and 6 months
Title
Probing depth
Description
continuous (mm)
Time Frame
3 months and 6 months
Title
esthetics
Description
numerical using Root coverage esthetic score (RES)
Time Frame
6 months
Title
patient's satisfaction
Description
categorical via assessment of patient-related criteria using a 3-point rating scale
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Gender: Male and Female
Age: >20 years
Have RT1 and RT2 gingival recession
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa El Sayed, Ass. lec.
Phone
00201092221005
Email
drmarwah82@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Re da Abd EL Rahman, Ass. Prof.
Phone
00201006608568
Email
dr.a.reda@gmail.com
Facility Information:
Facility Name
Cairo university, Faclty of dentistry
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Re Abd El Raman, Ass. Prof.
Phone
00201006608568
Email
dr.a.reda@gmail.com
First Name & Middle Initial & Last Name & Degree
Mona Sa Darhous, Professor
Phone
00201223155955
Email
mona.darhous@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
publishing in an international journal
IPD Sharing Time Frame
1 year
Learn more about this trial
Using Inverted Periosteal Pedicle Flap in Treatment of Gingival Recession
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