Site Preservation Was Performed Through an Open Healing Oral Restorative Membrane

NCT07334067 | Not Yet Recruiting DMC

• 1 other identifier: 2024-093（R）
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, an open healing oral restoration membrane was used for site preservation in the esthetic area after tooth extraction to maintain the space for tooth extraction and bone formation. Clinical observation and cone-beam computed tomography (CBCT) were used to comprehensively evaluate the effect of this operation on promoting the growth of soft and hard tissues, and to provide a new treatment method for site preservation in the esthetic area of clinical anterior teeth.

Conditions

Soft Tissue Healing; Anterior Dental Aesthetic Area; Site Preservation

Outcome Measures

Primary Outcomes (1)

• soft tissue healing efficiency

  After calibrating the magnification ratio of the tooth extraction wound photos, the reduction ratio of the tooth extraction wound area at 7 days, 14 days, 1 month, and 3 months after surgery was calculated based on the immediate postoperative tooth extraction wound photos to evaluate the soft tissue healing efficiency.

  Immediately after surgery, 7 days, 14 days and 1 month after surgery

Secondary Outcomes (1)

• Bone healing efficiency

  Preoperative and postoperative 3 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Tooth extraction in the aesthetic area of the anterior teeth with the expansion and flap were reduced in the operative area. Site preservation surgery was performed using Bio-oss (0.5g, Small granule) and bio-gide (25\*25mm size) . The gums were closely drawn and sutured.

Procedure: site preservation surgery with close sutures

Experimental group

EXPERIMENTAL

Tooth extraction in the aesthetic area of the anterior teeth without the expansion and flap were reduced in the operative area. Site preservation surgery was perfomed using Bio-oss (0.5g, Small granule) and Yinlife PCL membrane (25\*25mm size) , with opened wound.

Procedure: site preservation surgery with open healing

Interventions

site preservation surgery with open healing PROCEDURE

Tooth extraction in the aesthetic area of the anterior teeth without the expansion and flap were reduced in the operative area. Site preservation surgery was perfomed using Bio-oss (0.5g, Small granule) and Yinlife PCL membrane (25\*25mm size) , with opened wound.

Experimental group

site preservation surgery with close sutures PROCEDURE

Tooth extraction in the aesthetic area of the anterior teeth with the expansion and flap were reduced in the operative area. Site preservation surgery was performed using Bio-oss (0.5g, Small granule) and bio-gide (25\*25mm size) . The gums were closely drawn and sutured.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : Age ≥18 years old
• : The affected teeth did not have the conditions for immediate implant placement: thin gingival biotype, labial bone plate thickness \<1 mm, the labial bone plate was missing, the distance between the labial bone plate crest and the cemento-enamel junction\>3 mm
• : No systemic diseases and good oral hygiene
• : Be willing to receive treatment and regular follow-up and review, and signed the informed consent

You may not qualify if:

• : Uncontrolled systemic diseases, such as heart, liver and kidney diseases, systemic infections, diabetes, etc
• : Women who are pregnant or lactating
• : Taking bisphosphonates, glucocorticoids and other drugs that affect bone metabolism for a long time or within 5 years
• : Patients receiving oral and maxillofacial radiotherapy in the past five years
• : Patients suffering uncontrolled periodontal disease

Sponsors & Collaborators

• The Dental Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

Stomatology Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

CN (1)