Comparison of Coronally Advanced Lingual Flap to Modified MPI for Flap Advancement in Partially Edentulous Patients

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.

Comparison of cronally advanced lingual flap to modified periosteal releasing incision (MPRI)

Study Overview

• Status: Unknown
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Procedure: The coronally advanced lingual flap; Procedure: Modified periosteal releasing Incision

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

• Study Type: Interventional
• Enrollment (Anticipated): 7
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noha Fa Diab, master; Phone Number: +02 01222563478; Email: diab.noha@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 0220
    • Recruiting
    • Noha Diab
    • Contact: noha diab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Coronally Advanced Lingual Flap; 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.	Procedure: The coronally advanced lingual flap; : 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.
Active Comparator: Modified periosteal releasing Incision; 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	Procedure: Modified periosteal releasing Incision; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flap advancement	Flap advancement will be measured as a difference between the value before and after in millimeters using periodontal probe.	"10 minutes"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Week
Postoperative membrane exposure	Postoperative membrane exposure will be evaluated at 1, 2, 3, 4, 12 weeks using a periodontal probe in millimeters.	12 Weeks
bone density	bone density will before and after with cone beam computed tomography (CBCT)	12 Weeks
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.	"1 week"

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Egypt Recruiting, Cairo, Egypt, 02

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): August 25, 2018

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 15, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2018
• Last Update Submitted That Met QC Criteria: March 14, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Ridge Augmentation; Titanium mesh; Flap advancement
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: cebc. cairouniversity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No