Site Preservation Was Performed Through an Open Healing Oral Restorative Membrane

The Application and Efficacy of Dental Prosthesis Membrane in the Preservation of Anterior Esthetic Area After Tooth Extraction

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Soft Tissue Healing; Site Preservation; Anterior Dental Aesthetic Area
• Intervention / Treatment: Procedure: site preservation surgery with close sutures; Procedure: site preservation surgery with open healing

Detailed Description

The anterior tooth region is the key area of aesthetics, which has always been the difficulty and hotspot of implant restoration. In tooth extraction caused by various diseases, the amount of new bone in the tooth extraction fossa often cannot reach the level of the original alveolar ridge, especially the damage to the lip and buccal bone plate is more serious, resulting in insufficient bone mass when the implant is implanted in the later stage. Therefore, bone increment surgery is often used to reconstruct the collapsed alveolar ridge. Among them, site preservation has been widely adopted because of its effective promotion of autologous bone regeneration, simple operation and strong operability. Site preservation is performed by bone grafting on the extraction fossa immediately after tooth extraction to preserve the height and width of the remaining alveolar ridge as much as possible, and retain the corresponding amount of soft tissue, so as to provide sufficient bone mass for later implantation surgery and repair, so as to obtain good aesthetic repair effects.

However, there is currently a lack of oral biofilm that can be opened for healing. After filling bone meal and covering barrier biofilm, the mucosal tissue needs to be fully reduced and then tightly sutured. Sufficient reduction of gingival soft tissue in the aesthetic area of the anterior teeth will undoubtedly increase the surgical wound, and obvious scars will appear in the early stage of repair, seriously affecting the aesthetic appearance. Therefore, in order to simplify the surgical plan of site preservation, reduce trauma, and obtain stable bone growth and good soft tissue morphology, this project proposed to use oral repair membrane with open healing to replace the commonly used clinical collagen membrane for site preservation of the aesthetic area of the anterior teeth.

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Stomatology Hospital, Zhejiang University School of Medicine
      • Contact: Jue Shi, Doctor; Phone Number: +86 13757171359; Email: dentistsj@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1: Age ≥18 years old

  2: 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

  3: No systemic diseases and good oral hygiene

  4: Be willing to receive treatment and regular follow-up and review, and signed the informed consent

Exclusion Criteria:

• 1: Uncontrolled systemic diseases, such as heart, liver and kidney diseases, systemic infections, diabetes, etc

  2: Women who are pregnant or lactating

  3: Taking bisphosphonates, glucocorticoids and other drugs that affect bone metabolism for a long time or within 5 years

  4: Patients receiving oral and maxillofacial radiotherapy in the past five years

  5: Patients suffering uncontrolled periodontal disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; 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; 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.
Experimental: Experimental group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone healing efficiency	NNT Viewer software was used to calibrate CBCT images before and 3 months after surgery. The same section position was used to extract anterior teeth. The area marked by periodontal ligament outside the root before surgery was used as the extraction socket area, and the black corresponding to the blank in the postoperative image was used to represent the unhealed extraction socket. It was used to evaluate the healing efficiency of bone tissue.	Preoperative and postoperative 3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024-093（R）

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No