Flap Advancement Techniques in Ridge Augmentation

Flap Advancement Clinical Trial

Official title:

Clinical and Radiographic Comparison of Coronally Advanced Lingual Flap to Periosteal Releasing Incision for Flap Advancement in Partially Edentulous Patients Undergoing Guided Bone Regeneration Using Titanium Mesh: RCT.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03071523
• Other study ID #: CEBD-2017-01-130
• Status: Completed
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: July 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Different augmentation techniques has been proposed to resolve problem of hard and/or soft tissue ridge defects to enable dental implant placement. Guided bone regeneration GBR procedure is considered as an acceptable reliable surgical procedure for localized ridge augmentation. Exposure of the membrane used for the GBR is considered a major disadvantage of this procedure. In order to avoid such complication, various flap advancement techniques have been proposed such as Periosteal releasing incision,Double-Flap Incision,Coronally advanced lingual flap. The study compare between the flap advancement provided by Periosteal releasing incision,versus,Coronally advanced lingual flap in the treatment of class 1 ridge defect.

Description:

Two arms RCT will be conducted as followed:

Group A (intervention):

Full-thickness crestal incision will be made over the edentulous ridge followed by one full-thickness vertical incision on the buccal side. On the buccal side, full thickness mucoperiosteal flap will be raised with horizontal incision 1-3 mm in depth performed in the buccal flap. On the lingual side, a full-thickness mucoperiosteal flap will be elevated until reaching the mylohyoid line. A band of connective tissue continuing with the epimysium of the mylohyoid muscle is usually located in the first molar area, and is1 to 2 cm wide in a mesiodistal direction. This band is inserted into the inner part of the lingual flap approximately5 mm from the crest in an apical direction. A blunt instrument will be inserted below that connective band, and, with gentle traction in the coronal direction, this muscular insertion should be detached freeing the lingual flap from the mylohyoid muscle. Then Xenograft and Ti-mesh will be used to augment the defective site and the flap will then be sutured with interrupted sutures.

Group B ( control ):

Full-thickness crestal incision will be made over the edentulous ridge followed by one full-thickness vertical incision on the buccal side and a full thickness flap will be raised. Xenograft and Ti-mesh will be used to augment the defective site then incremental incisions of 1-3 mm into the periosteum and submucosa will be used to advance the muco-periosteal flap. The flap will then be sutured with interrupted sutures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 20, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Partially edentulous patients in the mandibular posterior region.

• Patients with healthy systemic conditions.

• Insufficient ridge width (< 5mm).

• Presence of proper inter-arch space for placement of the implant prosthetic part with adequate soft tissue biotype (= 2mm).

• No clinical evidence of active periodontal disease or oral infections.

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.

• History of bone associated diseases or medication affecting bone metabolism e.g. bisphosphonate treatment.

• History of radiation therapy in the head or neck region.

• Current antitumor chemotherapy.

• Pregnancy.

• Inflammatory and autoimmune diseases of the oral cavity.

Related Conditions & MeSH terms

• Flap Advancement
• Primary Wound Closure

Intervention

Procedure:
• coronally advanced lingual flap
Full-thickness crestal incision will be made over the edentulous ridge followed by one full-thickness vertical incision on the buccal side. On the buccal side, full thickness mucoperiosteal flap will be raised with horizontal incision 1-3 mm in depth performed in the buccal flap. On the lingual side, a full-thickness mucoperiosteal flap will be elevated until reaching the mylohyoid line. A band of mylohyoid muscle is inserted into the inner part of the lingual flap approximately 5 mm from the crest in an apical direction. A blunt instrument will be inserted below that connective band, and, with gentle traction in the coronal direction, this muscular insertion should be detached freeing the lingual flap from the mylohyoid.
• periosteal releasing incision
Full-thickness crestal incision will be made over the edentulous ridge followed by one full-thickness vertical incision on the buccal side and a full thickness flap will be raised. Xenograft and Ti-mesh will be used to augment the defective site then incremental incisions of 1-3 mm into the periosteum and submucosa will be used to advance the muco-periosteal flap. The flap will then be sutured with interrupted sutures.

Locations

Country	Name	City	State
Egypt	Rasha Attia	Cairo	Cairo Governorate

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	Using periodontal probe in millimeters.	Intra-operative after flap release by either periosteal releasing incision or lingual flap advancment
Secondary	Bone width gain	Using Cone Bean Computed tomography in millimeters.	9 month
Secondary	Postoperative membrane exposure	Using periodontal probe in millimeters.	9 month
Secondary	Postoperative Pain	VAS scale	2 weeks
Secondary	Postoperative swelling	VAS scale	2 weeks