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

• ClinicalTrials.gov Identifier: NCT03466840
• Recruitment Status: Unknown
• First Posted: March 15, 2018
• Last Update Posted: March 15, 2018
• Sponsor: Cairo University
• Information provided by (Responsible Party): Noha Fathi Messalam Diab, Cairo University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Alveolar Bone Loss	Procedure: The coronally advanced lingual flap; Procedure: Modified periosteal releasing Incision	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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.
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: January 1, 2018
• Estimated Primary Completion Date: July 1, 2018
• Estimated Study Completion Date: August 25, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Flap advancement [ Time Frame: "10 minutes" ]
   Flap advancement will be measured as a difference between the value before and after in millimeters using periodontal probe.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

Contact: Noha Fa Diab, master; 01222563478 ext +02; diab.noha@gmail.com

Locations

Egypt

Noha Diab; Recruiting

Cairo, Egypt, 0220

Contact: noha diab

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: Egypt Recruiting; Cairo, Egypt, 02

More Information

• Responsible Party: Noha Fathi Messalam Diab, principal investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT03466840
• Other Study ID Numbers: cebc. cairouniversity
• First Posted: March 15, 2018
• Last Update Posted: March 15, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Noha Fathi Messalam Diab, Cairo University:

Ridge Augmentation; Titanium mesh; Flap advancement

Additional relevant MeSH terms:

Alveolar Bone Loss; Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases