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

Alveolar Bone Loss Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03466840
• Other study ID #: cebc. cairouniversity
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2018
• Last updated: March 14, 2018
• Start date: January 1, 2018
• Est. completion date: August 25, 2018

Study information

• Verified date: March 2018
• Source: Cairo University
• Contact: Noha Fa Diab, master
• Phone: 01222563478
• Email: diab.noha[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7
• Est. completion date: August 25, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Noha Diab	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flap advancement	Flap advancement will be measured as a difference between the value before and after in millimeters using periodontal probe.	"10 minutes"
Secondary	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
Secondary	Postoperative membrane exposure	Postoperative membrane exposure will be evaluated at 1, 2, 3, 4, 12 weeks using a periodontal probe in millimeters.	12 Weeks
Secondary	bone density	bone density will before and after with cone beam computed tomography (CBCT)	12 Weeks
Secondary	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"