Horizontal Ridge Augmentation Using Polyvinylidene Fluoride Versus Titanium Mesh Membranes

NCT07095530 | Completed DMC

• 2 other identifiers: PVDF membrane in HRAcommittee 1059
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of a new PVDF non-resorbable membrane versus Titanium Mesh in the treatment of horizontal ridge defects prepared for implant placement

Conditions

Horizontal Alveolar Bone Loss

Keywords

Horizontal ridge augmentation; PVDF; Titanium Mesh

Outcome Measures

Primary Outcomes (1)

• horizontal ridge augmentation

  determined from a CBCT radiograph taken with the same machine (SCANORA® 3Dx CBCT scanner, Finland). This measurement was evaluated 2 mm below the highest crestal point. At baseline and six months after surgery, the difference between the two measurements was calculated using the formula: HBG (mm) = Postoperative width - Preoperative width.

  After 6 months

Study Arms (2)

control group

PLACEBO COMPARATOR

This study conducted two main surgical interventions: (T0) one for bone reconstruction and (T1) another for membrane removal following exposure. During the first surgery (T0), patients rinsed with a 0.2% chlorhexidine mouthwash (Eva Pharma, Giza, Egypt) for 60 seconds. All selected sites were anesthetized using articaine hydrochloride 4% with adrenaline (1:100,000) (Artinibsa, Inibsa Spain, Wedjat Pharma). A mid-crestal incision was made, extending to a sulcular incision of adjacent teeth, which included one mesial tooth and two distal teeth. In the edentulous area, the flap extended 3-4 mm posterior to the defect site, along with two vertical releasing incisions. A full-thickness mucoperiosteal flap was raised with a mucoperiosteal elevator (Molt Elevator No. 9, Hu-Friedy®, Hu-Friedy Mfg. Co., LLC. USA) to expose the defect site and adjacent bone; the buccal flap extended apically 5 mm beyond the defect site with a periosteal releasing incision (PRI) for flap mov

Procedure: titanium membrane

study group

ACTIVE COMPARATOR

This study conducted two main surgical interventions: (T0) one for bone reconstruction and (T1) another for membrane removal following exposure. During the first surgery (T0), patients rinsed with a 0.2% chlorhexidine mouthwash (Eva Pharma, Giza, Egypt) for 60 seconds. All selected sites were anesthetized using articaine hydrochloride 4% with adrenaline (1:100,000) (Artinibsa, Inibsa Spain, Wedjat Pharma). A mid-crestal incision was made, extending to a sulcular incision of adjacent teeth, which included one mesial tooth and two distal teeth. In the edentulous area, the flap extended 3-4 mm posterior to the defect site, along with two vertical releasing incisions. A full-thickness mucoperiosteal flap was raised with a mucoperiosteal elevator (Molt Elevator No. 9, Hu-Friedy®, Hu-Friedy Mfg. Co., LLC. USA) to expose the defect site and adjacent bone; the buccal flap extended apically 5 mm beyond the defect site with a periosteal releasing incision (PRI) for flap mov

Procedure: titanium membrane

Interventions

titanium membrane PROCEDURE

surgical treatment for horizontal ridge augmentation by titanium mesh and PVDF membrane

Also known as: PVDF membrane, titanium mesh, xenograft bone, collagen membrane

control group; study group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All patients were diagnosed with Class I (Horizontal ridge deficiency) according to Seibert's classification of alveolar ridge deficiencies (Seibert, 1983) .Maxilla and mandible partial edentulism, not more than 2 teeth missing with D3, D4 bone density(Smith \& Zarb, 1989).
• Presence of a horizontally deficient edentulous ridge (Low \< 5 mm) (Misch et al., 2021).
• Good systemic health (ASA I ) (Böhmer et al., 2021).
• Patients aged 18-55 years.
• Non-smokers or light smokers (\<10 cigarettes/day).

You may not qualify if:

• Poor oral hygiene with BOP \> 20%.
• Heavy smoking (more than 10 cigarettes per day).
• local and systemic acute infection.
• Patients who received radiotherapy in the head and neck within the previous five years.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Egypt

Cairo, Minya Governorate, 12345, Egypt

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: PVDF membrane with bone graft used for horizontal ridge augmentation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of oral periodontology oral medicine and diagnosis

Model Details: A total of forty-two participants were randomly allocated in a 1:1 ratio into two distinct groups. The control group (n = 21) received a Titanium mesh membrane, which was covered with a collagen membrane, while the study group (n = 21) was treated with a Polyvinylidene fluoride (PVDF) membrane. Participants were randomized using a computer-generated method (www.random.org ), ensuring an unbiased distribution of subjects into each group. This process was meticulously overseen by an independent researcher to maintain the integrity of the trial. To further safeguard against bias, allocation concealment was rigorously implemented through the use of sealed, opaque envelopes, which secured the treatment assignments until the point of implementation. This comprehensive approach aimed to enhance the validity and reliability of the research findings.

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 31, 2025
• Study Start: June 1, 2024
• Primary Completion: January 17, 2025
• Study Completion: January 20, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

EG (1)