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

Guided Bone Regeneration Clinical Trial

Official title:

Radiographic And Clinical Evaluation of Horizontal Bone Gain in the Lower Posterior Partially Edentulous Patients Comparing the Stabilization of The Resorbable Collagen Membrane With and Without Tacs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06257225
• Other study ID #: PerioMIU1029
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Yahya Amer, PhD
• Phone: +201006194329
• Email: yahia.hassan[@]miuegypt.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: June 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Guided Bone Regeneration
• Mouth, Edentulous

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Misr International University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Horizontal bone gain assessed radiographically (mm)	Using CBCT	Baseline , 4 month
Secondary	Horizontal bone gain assessed clinically (mm)	Bone Caliper	Baseline , 4 month
Secondary	Amount of Pain	Visual Analogue Scale (VAS) (Price et al., 1983)	7 days
Secondary	Amount of Pain	Number of analgesics consumed daily for 7 days	7 days
Secondary	Patient satisfaction	Questionnaire - Binary	4 month
Secondary	Surgical Time	Stop Watch	During Surgery
Secondary	Histological Evaluation	Core Biopsy	4 month