Comparison of Double-Flap Incision, Modified Periosteal Releasing Incision, and Coronally Advanced Lingual Flap to Periosteal Releasing Incision for Flap Advancement

NCT03787342 | Completed

• 1 other identifier: PERIO3:7:1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Guided Bone Regeneration (GBR) is a reliable method to augment insufficient bone volume for implant placement. Membrane exposure is a major complication which is avoided by tension free primary closure. Classically Periosteal Releasing Incision (PRI) is performed to advance the flap. The aim of this trial is to compare Double Flap Incision (DFI), Modified Periosteal Releasing Incision (MPRI) \& Coronally Advanced Lingual Flap (CALF) to PRI in terms of flap advancement, postoperative pain \& swelling, membrane exposure and the amount of bone gain clinically and radiographically in GBR procedures.

Conditions

Flap Advancement

Keywords

Periosteal Releasing Incision, Modified Periosteal Releasing Incision, Coronally Advanced Lingual Flap, Double Flap Incision, Titanium mesh, GBR

Outcome Measures

Primary Outcomes (1)

• Flap advancement

  Flap advancement in millimeters will be measured as the difference before and after Double flap Incision, Modified Periosteal Releasing Incision, Coronally Advanced Lingual Flap, and Periosteal Releasing Incision in millimeters using periodontal probe.

  Intraoperative

Secondary Outcomes (2)

• Postoperative Pain

  7 days postoperatively

• Postoperative Swelling

  7 days postoperatively

Other Outcomes (2)

• Postoperative membrane exposure

  will be evaluated at 1, 2, 3, 4, 12, 24 weeks postoperative

• Bone width gain

  preoperative & 6 months postoperative.

Study Arms (4)

DFI "Double Flap Incision"

EXPERIMENTAL

A full-thickness crestal incision will be made over the edentulous ridge, and then one partial-thickness vertical incision will be made on the buccal side. A partial-thickness flap will be raised first to separate the mucosal layer from the overlying periosteum. Subsequently, the periosteal layer will be elevated to expose the underlying alveolar process. Xenograft and Ti-mesh will be used to augment the defective site then periosteal flap will be sutured first, with periosteal sutures securing the regenerative site. Then the mucosal flap will be closed.

Procedure: Double Flap Incision

MPRI "Modified PRI"

EXPERIMENTAL

A full-thickness muco-periosteal flap is reflected on the buccal side (crestal incision and two vertical releasing incisions). Near the base of mucoperiosteal flap, the periosteum is incised less than 0.5mm in depth, creating two segments, "coronal segment" and "apical segment," of the periosteal flap. The shallow incision helps in preventing damage to the submucosal layer. 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 with sweeping motion to allow flap advancement.

Procedure: Modified Periosteal Releasing Incision

CALF "Coronally Advanced Lingual Flap"

EXPERIMENTAL

A full-thickness crestal incision will be performed in the keratinized tissue from the distal surface of the more distal tooth to the retromolar pad. The flap design will be continued intrasulcularly on both vestibular and lingual sides of the mesial portion of the flap, buccally, it will be finished with a vertical releasing incision. On the lingual side, a full-thickness mucoperiosteal flap will be elevated until reaching the mylohyoid line. Then, using a blunt instrument it will be localized a connective tissue band continuing with the epimysium of the mylohyoid muscle. The blunt instrument will be inserted below this connective band, and, with gentle traction in the coronal direction, this muscular insertion will be detached from the lingual flap.

Procedure: Coronally Advanced Lingual Flap

PRI "Periosteal Releasing Incision"

ACTIVE COMPARATOR

A 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 as a whole unit.

Procedure: Periosteal releasing incision

Interventions

Double Flap Incision PROCEDURE

A full-thickness crestal incision will be made over the edentulous ridge, and then one partial-thickness vertical incision will be made on the buccal side. A partial-thickness flap will be raised first to separate the mucosal layer from the overlying periosteum. Subsequently, the periosteal layer will be elevated to expose the underlying alveolar process. Xenograft and Ti-mesh will be used to augment the defective site then periosteal flap will be sutured first, with periosteal sutures securing the regenerative site. Then the mucosal flap will be closed.

Also known as: DFI

DFI "Double Flap Incision"

Modified Periosteal Releasing Incision PROCEDURE

A full-thickness muco-periosteal flap is reflected on the buccal side (crestal incision and two vertical releasing incisions). Near the base of mucoperiosteal flap, the periosteum is incised less than 0.5mm in depth, creating two segments, "coronal segment" and "apical segment," of the periosteal flap. The shallow incision helps in preventing damage to the submucosal layer. 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 with sweeping motion to allow flap advancement.

Also known as: MPRI

MPRI "Modified PRI"

Coronally Advanced Lingual Flap PROCEDURE

A full-thickness crestal incision will be performed in the keratinized tissue from the distal surface of the more distal tooth to the retromolar pad. The flap design will be continued intrasulcularly on both vestibular and lingual sides of the mesial portion of the flap, buccally, it will be finished with a vertical releasing incision. On the lingual side, a full-thickness mucoperiosteal flap will be elevated until reaching the mylohyoid line. Then, using a blunt instrument it will be localized a connective tissue band continuing with the epimysium of the mylohyoid muscle. The blunt instrument will be inserted below this connective band, and, with gentle traction in the coronal direction, this muscular insertion will be detached from the lingual flap.

Also known as: CALF

CALF "Coronally Advanced Lingual Flap"

Periosteal releasing incision PROCEDURE

PRI "Periosteal Releasing Incision"

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: 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 (≥ 2mm).
• No clinical evidence of active periodontal disease or oral infections.

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.
• 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 anti-tumor chemotherapy.
• Pregnancy.
• Inflammatory and autoimmune diseases of the oral cavity.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

Study Officials

• Nada Zazou, Masters

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Care provider and investigator cannot be blinded as they are involved in the surgical procedure so blinding is not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, assistant Lecturer, Modern Sciences and Arts University (MSA).

Model Details: Three Groups of intervention compared to one group of comparator. Each group contains 10 patients.

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: December 26, 2018
• Study Start: December 1, 2016
• Primary Completion: August 30, 2019
• Study Completion: September 30, 2019
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

EG (1)