A Comparison Between Primary and Secondary Flap Coverage in Extraction Sites: A Pilot Study

Completed · Not applicable

Conditions studied: Loss of Teeth Due to Extraction

In brief

This study is being conducted to compare the outcomes of two separate surgical techniques used in tooth extraction and ridge preservation. Ridge preservation is done to potentially minimize the amount of bone loss that occurs between the tooth extraction and implant or bridge placement, as compared to leaving the extraction site empty. There are two techniques that are commonly used for these procedures, either to close the surgical site of the extracted tooth with sutures (closed flap technique) or to leave the extraction site open to heal naturally (open flap technique). In the open flap technique there will be sutures used to secure and hold down the material used to cover the wound, called a non-resorbable membrane. The flaps will remain in their natural position, the site will fill up naturally with new tissue from the bottom up and then close itself in from the sides. The investigators want to see which technique offers better healing and reduces bone loss.

Key facts

Study ID

NCT03136913

Run by

Tufts University

People needed

13

Starts

2015-02-17

Expected to finish

2016-10-11

Last updated by the study team

2021-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patient who is treatment planned at Tufts University School of Dental Medicine (TUSDM) for extraction and future implant placement and meet all medical and dental requirements of the TUSDM periodontology clinic for periodontal surgery (e.g., subjects with no diseases or medication allergies contraindicating periodontal surgery).
• Patient must have bilateral extraction (canine to molar) sites of teeth located on the same arch (e.g. upper right and upper left) treatment planned for future implant placement at TUSDM.
• The number of teeth planned for extraction (either one or two adjacent) and ridge preservation should match the same number of teeth (either one or two adjacent) from the contra-lateral side on the same arch.
• Presence of at least 3 intact bony walls and at least half of the fourth bony wall at each site as determined by bone sounding at Visit 1.

You may not qualify if…

• Have any known disease that interferes with periodontal surgery and would not allow the patient to be treatment planned for the procedures in the TUSDM periodontology clinic (e.g., severe anemia, low white blood cell count, bleeding or coagulation disorder, uncontrolled hypertension (150/90), recent myocardial infarction (within 6 months of enrollment), diabetes (HbA1C ≥7%), HIV/AIDS (self-reported), history of or currently undergoing head and neck radiation, history of or currently taking bisphosphonates).
• Subject who has a disease or condition that may affect hard and soft tissue healing (e.g., previous or current head and neck radiation therapy, long term steroid use defined as more than two weeks in the past two years).
• Subject who has diseases that affect bone metabolism (e.g., osteoporosis, osteopenia).
• Pregnancy (self-reported)
• Current Smokers
• Extraction socket with > 50% bone loss on the buccal or lingual/palatal bone as determined by bone sounding at Visit 1.
• Allergic to gentamycin, povidone-iodine, or surfactants as trace amounts may be contained in the MinerOss®

Where it is running

• Tufts University School of Dental Medicine — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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