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Site Preservation Was Performed Through an Open Healing Oral Restorative Membrane

ConditionsSite PreservationSoft Tissue HealingAnterior Dental Aesthetic Area
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Dental Hospital of Zhejiang University School of Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1: Age ≥18 years old

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • site preservation surgery with open healing

    Procedure/Surgery

    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.

  • site preservation surgery with close sutures

    Procedure/Surgery

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Experimental groupExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
Preoperative and postoperative 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Dental Hospital of Zhejiang University School of Medicine

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: