Evaluation of Horizontal Bone Gain in the Lower Posterior Partially Edentulous Patient Comparing the Stabilization of Membranes With and Without Tacs

NCT ID: NCT06257225

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2024-06-30

Brief Summary

To address the gap of knowledge in comparing between the bone augmentation outcomes with or without tacks for membrane stabilization

Conditions

Guided Bone Regeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Patient showing horizontal defect and treated with GBR stabilized with Tacs

Fixation

Group Type: ACTIVE_COMPARATOR

Guided Bone regeneration

Intervention Type: PROCEDURE

After local anesthesia, a crestal incision will be performed followed by full-thickness mucoperiosteal flap elevation Flap advancement will be attained through periosteal scoring of the buccal; The resorbable collagen membrane (Bio Gide, Geistlich AG) will be trimmed to the defect size. Xenograft (Bio-Oss) together with scrapped autogenous bone will be mixed and placed at the surgical site. The membrane will positioned over the graft and tucked into the lingual flap. Patient allocation concealment will be broken and the patients will be randomly assigned into two groups Patients receiving horizontal bone augmentation with resorbable collagen membrane stabilized with no tacks. The first layer will be closed with horizontal mattress sutures placed 4 mm from the incision line, and single interrupted sutures are used to close the edges of the flap. Vertical incisions are closed using single interrupted sutures and mattress suture should remain in place for at least 2 to 3 weeks

Patient showing horizontal defect and treated with GBR stabilized with no Tacs

No Fixation

Group Type: EXPERIMENTAL

Guided Bone regeneration

Intervention Type: PROCEDURE

After local anesthesia, a crestal incision will be performed followed by full-thickness mucoperiosteal flap elevation Flap advancement will be attained through periosteal scoring of the buccal; The resorbable collagen membrane (Bio Gide, Geistlich AG) will be trimmed to the defect size. Xenograft (Bio-Oss) together with scrapped autogenous bone will be mixed and placed at the surgical site. The membrane will positioned over the graft and tucked into the lingual flap. Patient allocation concealment will be broken and the patients will be randomly assigned into two groups Patients receiving horizontal bone augmentation with resorbable collagen membrane stabilized with no tacks. The first layer will be closed with horizontal mattress sutures placed 4 mm from the incision line, and single interrupted sutures are used to close the edges of the flap. Vertical incisions are closed using single interrupted sutures and mattress suture should remain in place for at least 2 to 3 weeks

Interventions

Guided Bone regeneration

After local anesthesia, a crestal incision will be performed followed by full-thickness mucoperiosteal flap elevation Flap advancement will be attained through periosteal scoring of the buccal; The resorbable collagen membrane (Bio Gide, Geistlich AG) will be trimmed to the defect size. Xenograft (Bio-Oss) together with scrapped autogenous bone will be mixed and placed at the surgical site. The membrane will positioned over the graft and tucked into the lingual flap. Patient allocation concealment will be broken and the patients will be randomly assigned into two groups Patients receiving horizontal bone augmentation with resorbable collagen membrane stabilized with no tacks. The first layer will be closed with horizontal mattress sutures placed 4 mm from the incision line, and single interrupted sutures are used to close the edges of the flap. Vertical incisions are closed using single interrupted sutures and mattress suture should remain in place for at least 2 to 3 weeks

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with at least 1 missing tooth in the posterior mandibular area Patients with an age above 18 years Systemically healthy patients

Healed alveolar ridge for implant placement with:

• Deficient buccolingual dimension ( ≤5mm)
• Sufficient vertical height (≥ 10 mm)
• Sufficient mesio-distal width (≥ 6.5 mm) Inter-arch space ≥ 7 mm to allow space for implant-supported crown Presence of neighboring and opposing dentition Soft tissue phenotype with keratinized tissue width (KTW) (≥2 mm) and gingival thickness (≥2 mm) Good oral hygiene Cooperative patients who accepted the trial follow up period and sign the informed consen

Exclusion Criteria

• Systemic diseases or medications that might affect bone metabolism, increase surgical risk or complicate post-operative healing Untreated periodontal diseases History of radiation therapy to the head and neck Heavy smokers (≥ 10 cigarettes per day) Pregnant or lactating females Alcoholism or drug abuse Psychiatric problems Patients with signs of acute infection related to the area of interest

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Misr International University

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hani Elnahass

Professor of Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hani ElNahass, PhD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Omnia Tawfik, PhD

Role: STUDY_CHAIR

Cairo University

Central Contacts

Yahya Amer, PhD

Role: CONTACT

yahia.hassan@miuegypt.edu.eg

+201006194329

Other Identifiers

PerioMIU1029

Identifier Type: -

Identifier Source: org_study_id