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Evaluating the Effectiveness of Chitosan Nanofibrous Membranes as Barrier Membranes.

Evaluating the Efficacy of Chitosan/Polyvinyl Alcohol Nanofibrous Membranes as a Barrier Membranes Following Tooth Extraction.

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251001001
Enrollment
12
Registered
2025-10-01
Start date
2026-01-12
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bone resorption socket preservation Guided Bone Regeneration bone resorption bone regeneration

Interventions

Following tooth extraction, an impression will be taken for the socket, then the chitosan membrane will be sutured with resorbable sutures after ensuring clot formation inside the socket. 4 months lat
chitosan/polyvinyl alcohol nanofibrous membrane ,blood clot

Sponsors

Damascus University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1 patient who meets the ASA class I category. 2 patients aged between 18 - 65 years old. 3 patients who need at least 2 mandibular premolars extracted. 4 patients who are willing to participate in this clinical trial and attend all follow-ups.

Exclusion criteria

Exclusion criteria: 1 patient allergic to seafood or any of the membrane components. 2 patients with advanced periodontal disease, defined as probing pocket depth 5 millimeters or more with bleeding on probing at the extraction sites, or acute periapical infection at the extraction sites that cannot be fully debrided. 3 heavy smokers (more than 10 cigarettes per day). 4 alcoholics 5 pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Linear vertical bone height at surgery day and after 4 months calibrated periodontal probe will be used to measure the distance from the stent fixed reference holes to the alveolar crest at 4 specific points mid buccal mid lingual Mesial distal of the socket. ,Linear horizontal bone height at surgery day and after 4 months 3 fixed horizontal holes in the stent (1 mm,3mm,5mm) on buccal and lingual sides will be measured by graded probe,Bone density at surgery day and after 4 months percent of newly formed bone as seen in histologic sections.,Keratinized Tissue Width at 4th month re-entry distance in mm between gingival margin to the mucoginigival junction using the roll test

Secondary

MeasureTime frame
soft tissue healing 3rd and 7th post-extraction days Landry's healing scale,Soft Tissue Augmentation 4 months during re-entry surgery difference in mm between stent-to-bone distance and the stent-to-mucosa distance by graded probe,Adverse Events during the whole study period nature and severity of any harms will be reported as present or absent.

Countries

Syrian Arab Republic

Contacts

Public ContactKhaldoun Darwich

Damascus university

doctordarwich@gmail.com00963930664586

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026