Back to resultsComparison of Coronally Advanced Lingual Flap to Modified MPI for Flap Advancement in Partially Edentulous Patients
Primary Purpose
Alveolar Bone Loss
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
The coronally advanced lingual flap
Modified periosteal releasing Incision
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss focused on measuring Ridge Augmentation, Titanium mesh, Flap advancement
Eligibility Criteria
Inclusion Criteria:
- Partially edentulous patients in the mandibular posterior region.
- Patients with healthy systemic condition.
- Insufficient ridge width (< 5mm).
- Presence of proper inter-arch space for placement of the implant prosthetic part.
- Adequate soft tissue biotype (≥ 2 mm).
Exclusion Criteria:
- Patients with systemic conditions that may interfere with the results of the study.
- Patients with local pathological defects related to the area of interest.
- Unmotivated, uncooperative patients with poor oral hygiene.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as smoking, alcoholism or para-functional habits.
Sites / Locations
- Noha DiabRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
The Coronally Advanced Lingual Flap
Modified periosteal releasing Incision
Arm Description
On the lingual side of mandible, a full-thickness muco-periosteal flap is elevated until reaching mylohyoid line. Using a blunt instrument, a connective tissue band is localized continuing with the epimysium of the mylohyoid muscle and is inserted into the inner part of the lingual flap . The blunt instrument is inserted below the connective band, and with gentle traction in the coronal direction, this muscular insertion was detached from the lingual flap. Using a "periodontal probe" the amount of advancement is measured.
A full-thickness muco-periosteal flap is reflected on the buccal side. Near the base of muco-periosteal flap, the periosteum is incised less than 0.5mm in depth, creating two segments, "coronal segment" and "apical segment," of the periosteal flap. The flap is pulled with a pair of periodontal forceps laterally. Subsequently, the "lateral stretching" of the coronal segment of the flap is performed by applying pressure using the blunt face of scalpel blade, or a blunt instrument, with sweeping motion. This motion helps stretching the flap over the submucosa, thereby permitting the flap to be mobile.Using a "periodontal probe" the amount of advancement is measured
Outcomes
Primary Outcome Measures
Flap advancement
Flap advancement will be measured as a difference between the value before and after in millimeters using periodontal probe.
Secondary Outcome Measures
Postoperative Pain
Postoperative Pain will be recorded using Numerical Rating scale (NRS) The scores will be recorded postoperatively by the patient for the seven days of observation.
Postoperative membrane exposure
Postoperative membrane exposure will be evaluated at 1, 2, 3, 4, 12 weeks using a periodontal probe in millimeters.
bone density
bone density will before and after with cone beam computed tomography (CBCT)
postoperative swelling
postoperative swelling will be recorded using descriptive four point scale(Penarrocha et al.2006).The scores will be recorded postoperatively by the patient for the seven days of observation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03466840
Brief Title
Comparison of Coronally Advanced Lingual Flap to Modified MPI for Flap Advancement in Partially Edentulous Patients
Official Title
Clinical Assessment of Coronally Advanced Lingual Flap to Modified Periosteal Releasing Incision for Flap Advancement in Partially Edentulous Patients Undergoing Guided Bone Regeneration Using Titanium Mesh.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
July 1, 2018 (Anticipated)
Study Completion Date
August 25, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Comparison of cronally advanced lingual flap to modified periosteal releasing incision (MPRI)
Detailed Description
Clinical Assessment and Comparison of Coronally Advanced Lingual Flap to Modified Periosteal Releasing Incision for Flap Advancement in Partially Edentulous Patients Undergoing Guided Bone Regeneration Using Titanium Mesh: A Randomized Clinical Trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
Keywords
Ridge Augmentation, Titanium mesh, Flap advancement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
According to the allocation sequence obtained from the computer software the numbers will be written in small folded opaque papers and put in opaque sealed envelopes. All those papers will be ready before conducting any procedure. The patients will be allowed to pick his/her number from the pile of envelopes and will be assigned accordingly. The number of papers will decrease as each patient picks his number and so on.
Allocation
Randomized
Enrollment
7 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The Coronally Advanced Lingual Flap
Arm Type
Experimental
Arm Description
On the lingual side of mandible, a full-thickness muco-periosteal flap is elevated until reaching mylohyoid line. Using a blunt instrument, a connective tissue band is localized continuing with the epimysium of the mylohyoid muscle and is inserted into the inner part of the lingual flap . The blunt instrument is inserted below the connective band, and with gentle traction in the coronal direction, this muscular insertion was detached from the lingual flap. Using a "periodontal probe" the amount of advancement is measured.
Arm Title
Modified periosteal releasing Incision
Arm Type
Active Comparator
Arm Description
A full-thickness muco-periosteal flap is reflected on the buccal side. Near the base of muco-periosteal flap, the periosteum is incised less than 0.5mm in depth, creating two segments, "coronal segment" and "apical segment," of the periosteal flap. The flap is pulled with a pair of periodontal forceps laterally. Subsequently, the "lateral stretching" of the coronal segment of the flap is performed by applying pressure using the blunt face of scalpel blade, or a blunt instrument, with sweeping motion. This motion helps stretching the flap over the submucosa, thereby permitting the flap to be mobile.Using a "periodontal probe" the amount of advancement is measured
Intervention Type
Procedure
Intervention Name(s)
The coronally advanced lingual flap
Intervention Description
: A full-thickness crestal incision is performed from the distal surface of the more distal tooth to retromolar pad and finishing with releasing incision. On the lingual side, a full-thickness muco-periosteal flap was elevated until reaching mylohyoid line. Then using a blunt instrument, it was localized a connective tissue band continuing with the epimysium of the mylohyoid muscle. It is inserted into the inner part of the lingual flap about 5mm from the crest in an apical direction. The blunt instrument is inserted below the connective band, and with gentle traction in the coronal direction, this muscular insertion was detached from the lingual flap. Using a "periodontal probe", the amount of advancement is measured.
Intervention Type
Procedure
Intervention Name(s)
Modified periosteal releasing Incision
Intervention Description
A full-thickness muco-periosteal flap is reflected on the buccal side. Near the base of muco-periosteal flap, the periosteum is incised less than 0.5mm in depth, creating two segments, "coronal segment" and "apical segment," of the periosteal flap. The flap is pulled with a pair of periodontal forceps laterally. Subsequently, the "lateral stretching" of the coronal segment of the flap is performed by applying pressure using the blunt face of scalpel blade, or a blunt instrument, with sweeping motion. This motion helps stretching the flap over the submucosa, thereby permitting the flap to be mobile.Using a "periodontal probe" the amount of advancement is measured.
Primary Outcome Measure Information:
Title
Flap advancement
Description
Flap advancement will be measured as a difference between the value before and after in millimeters using periodontal probe.
Time Frame
"10 minutes"
Secondary Outcome Measure Information:
Title
Postoperative Pain
Description
Postoperative Pain will be recorded using Numerical Rating scale (NRS) The scores will be recorded postoperatively by the patient for the seven days of observation.
Time Frame
1 Week
Title
Postoperative membrane exposure
Description
Postoperative membrane exposure will be evaluated at 1, 2, 3, 4, 12 weeks using a periodontal probe in millimeters.
Time Frame
12 Weeks
Title
bone density
Description
bone density will before and after with cone beam computed tomography (CBCT)
Time Frame
12 Weeks
Title
postoperative swelling
Description
postoperative swelling will be recorded using descriptive four point scale(Penarrocha et al.2006).The scores will be recorded postoperatively by the patient for the seven days of observation.
Time Frame
"1 week"
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Partially edentulous patients in the mandibular posterior region.
Patients with healthy systemic condition.
Insufficient ridge width (< 5mm).
Presence of proper inter-arch space for placement of the implant prosthetic part.
Adequate soft tissue biotype (≥ 2 mm).
Exclusion Criteria:
Patients with systemic conditions that may interfere with the results of the study.
Patients with local pathological defects related to the area of interest.
Unmotivated, uncooperative patients with poor oral hygiene.
Patients with habits that may jeopardize the implant longevity and affect the results of the study such as smoking, alcoholism or para-functional habits.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noha Fa Diab, master
Phone
01222563478
Ext
+02
Email
diab.noha@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egypt Recruiting
Organizational Affiliation
Cairo, Egypt, 02
Official's Role
Principal Investigator
Facility Information:
Facility Name
Noha Diab
City
Cairo
ZIP/Postal Code
0220
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
noha diab
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of Coronally Advanced Lingual Flap to Modified MPI for Flap Advancement in Partially Edentulous Patients
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