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

NCT03466840 | Unknown

• 1 other identifier: cebc. cairouniversity
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alveolar Bone Loss

Keywords

Ridge Augmentation; Titanium mesh; Flap advancement

Outcome Measures

Primary Outcomes (1)

• Flap advancement

  Flap advancement will be measured as a difference between the value before and after in millimeters using periodontal probe.

  "10 minutes"

Secondary Outcomes (4)

• Postoperative Pain

  1 Week

• Postoperative membrane exposure

  12 Weeks

• bone density

  12 Weeks

• postoperative swelling

  "1 week"

Study Arms (2)

The Coronally Advanced Lingual Flap

EXPERIMENTAL

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

Modified periosteal releasing Incision

ACTIVE COMPARATOR

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

Interventions

The coronally advanced lingual flap PROCEDURE

: 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.

The Coronally Advanced Lingual Flap

Modified periosteal releasing Incision PROCEDURE

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.

Modified periosteal releasing Incision

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Noha Diab

Cairo, 0220, Egypt

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Egypt Recruiting

  Cairo, Egypt, 02

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noha Fa Diab, master

CONTACT

01222563478; diab.noha@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: March 15, 2018
• Study Start: January 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: August 25, 2018
• Last Updated: March 15, 2018

Record last verified: 2018-03

Locations

EG (1)