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Flap AdvancementNCT03787342

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

A study testing Double Flap Incision, Modified Periosteal Releasing Incision and Coronally Advanced Lingual Flap in people with Flap Advancement, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Flap Advancement
What is being tested?
Double Flap Incision, Modified Periosteal Releasing Incision and Coronally Advanced Lingual Flap
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteEgypt
Study dates
1 Dec 2016to 30 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Current anti-tumor chemotherapy.
  • Pregnancy.
  • Inflammatory and autoimmune diseases of the oral cavity.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Cairo University

    Cairo, 12613

Other trials in Egypt

About this study

Official title: Clinical and Radiographic Comparison of Double-Flap Incision, Modified Periosteal Releasing Incision, and Coronally Advanced Lingual Flap to Periosteal Releasing Incision for Flap Advancement in Partially Edentulous Patients Undergoing Guided Bone Regeneration Using Titanium Mesh: A Randomized Controlled Clinical Trial

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.

Read the detailed description

Study setting:

The patients will be assigned from the outpatient clinic of "The Faculty of Oral and Dental Medicine, Cairo University". Surgical procedures will be held in the periodontology clinic of the faculty. The recruited sample would be from the Egyptian urban and rural population.

Eligibility Criteria:

Inclusion criteria:

  1. Partially edentulous patients in the mandibular posterior region.
  2. Patients with healthy systemic condition.
  3. Insufficient ridge width (< 5mm).
  4. Presence of proper inter-arch space for placement of the implant prosthetic part.
  5. Adequate soft tissue biotype (≥ 2mm).
  6. No clinical evidence of active periodontal disease or oral infections.

Exclusion Criteria:

  1. Patients with systemic conditions that may interfere with the results of the study.
  2. Patients with local pathological defects related to the area of interest.
  3. Unmotivated, uncooperative patients with poor oral hygiene.
  4. Patients with habits that may jeopardize the implant longevity and affect the results of the study such as smoking, alcoholism or para-functional habits.
  5. History of bone associated diseases or medication affecting bone metabolism e.g.; bisphosphonate treatment.
  6. History of radiation therapy in the head or neck region.
  7. Current anti-tumor chemotherapy.
  8. Pregnancy.
  9. Inflammatory and autoimmune diseases of the oral cavity.

Interventions:

Pre-surgical phase:

  1. Medical History Questionnaire (MHQ): Patients will be interviewed to gather information regarding general and oral health and MHQ will be filled by the patient and will be kept among patient's record file.
  2. Clinical intra-oral examination
  • To ensure that the patient fulfills the previously mentioned defect-inclusion criteria.
  • Thorough intra-oral examination including teeth for caries, fracture, missing, or hopeless teeth and gingival-mucosal tissues for gingivitis, periodontitis, or oral lesions.
  • Referral for consultation or treatment if needed before the surgical phase.
  1. If the patient meets the clinical selection criteria then radiographic examination will be held. CBCT will be performed for adequate evaluation of bone width and density and to be kept as a record for postoperative comparison.
  2. Patients must sign an informed consent to clinical research previously approved by the Faculty of Oral and Dental Medicine, Cairo University.
  3. Eligible patients will be randomized before being enrolled in the study.

Surgical phase:

The patients will be assigned into four groups, all undergoing GBR using Ti- mesh and Xenograft as follow:

  • Group A: Flap advancement will be achieved using the DFI and this group will be assigned as a test group.
  • Group B: Flap advancement will be achieved using the MPRI and this group will be assigned as a test group.
  • Group C: Flap advancement will be achieved using the CALF and this group will be assigned as a test group.
  • Group D: Flap advancement will be achieved using the PRI and this group will be assigned as the control group.

Surgical Protocol:

The surgical procedures will be performed under local anesthesia

Group A:

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.

Group B:

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. This motion helps stretching the flap over the submucosa, thereby permitting the flap to be mobile and thus facilitates flap advancement (approximately 3-5mm). Xenograft and Ti-mesh will be used to augment the defective site.

Group C:

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.

Group D:

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.

Post-surgical instructions:

  • 1 g of Amoxicilin twice a day for 6 days with analgesic and anti-inflammatory drug, every 8 hours for 4 to 5 days, and 0.2% chlorexidine rinse 1min three times a day for 2 weeks, starting the day after surgery.
  • Immediately after surgery, ice packs will be applied onto the treated area and it is recommended that they be kept in place for at least 4 h.
  • Avoid tooth brushing especially at surgical sites, and soft diet to avoid trauma to the site of surgery for the first 3 weeks.
  • Subsequent visits will be scheduled for healing assessment and measurement recording and if necessary, a professional supra-gingival prophylaxis will be performed.
  • Sutures were removed after 2 week.
  • A removable prosthesis was never allowed, during healing, to avoid trans-mucosal pressure on the operated area.
Being tested
Double Flap Incision, Modified Periosteal Releasing Incision, Coronally Advanced Lingual Flap, Periosteal releasing incision
Keywords
Periosteal Releasing Incision, Modified Periosteal Releasing Incision, Coronally Advanced Lingual Flap, Double Flap Incision, Titanium mesh, GBR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Double Flap IncisionProcedure or surgery

    Also called DFI

    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.

  • Modified Periosteal Releasing IncisionProcedure or surgery

    Also called MPRI

    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.

  • Coronally Advanced Lingual FlapProcedure or surgery

    Also called CALF

    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.

  • Periosteal releasing incisionProcedure or surgery

Study groups in NCT03787342
Study groupRoleWhat they receive
DFI "Double Flap Incision"ExperimentalA 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.
Receives: Procedure: Double Flap Incision
MPRI "Modified PRI"ExperimentalA 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.
Receives: Procedure: Modified Periosteal Releasing Incision
CALF "Coronally Advanced Lingual Flap"ExperimentalA 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.
Receives: Procedure: Coronally Advanced Lingual Flap
PRI "Periosteal Releasing Incision"Active comparatorA 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.
Receives: Procedure: Periosteal releasing incision

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Intraoperative

Secondary outcomes (2)
  1. Postoperative Pain

    Pain will be recorded using Numerical Rating scale (NRS). It is a scale from 0 to 10. 0 indicates no pain and 10 indicates severe pain.

    Measured: 7 days postoperatively

  2. Postoperative Swelling

    will be recorded using Visual Analogue Scale (VAS). It is a scale from 0 to 4. 0 indicates no swelling while 4 indicates severe extra-oral swelling.

    Measured: 7 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2018
  2. Study start1 Dec 2016
  3. Primary completion30 Aug 2019
  4. Study completion30 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Three Groups of intervention compared to one group of comparator. Each group contains 10 patients.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03787342
Sponsor's protocol ID
PERIO3:7:1
Status last verified
Jul 2020
First submitted
27 Jul 2018
Last updated
22 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Double Flap Incision, Modified Periosteal Releasing Incision and Coronally Advanced Lingual Flap in people with Flap Advancement, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Flap advancement (time frame: Intraoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.

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Clinical Trial NCT03787342 | AzTrials