Tufts University School of Dental Medicine
Boston, Massachusetts, 02111, United States
NCT Number: NCT03136913
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02111, United States
Study design will be a single center, randomized controlled trial, split mouth designed study, to compare the bone dimensional changes following extraction and ridge preservation in surgical techniques that leave the flap open and closed.
The primary aim of this study is to evaluate the bone dimensional changes following extraction and ridge preservation with primary coverage (closed flap technique) in comparison to secondary intention (open flap technique).
The investigators hypothesize that the closed flap technique will have more potential to maintain vertical bone height when compared with the open flap technique, due to less susceptibility from infection and inflammation.
Secondary aim is to evaluate patients' self-report of postoperative discomfort. The investigators hypothesize that open flap technique will have less post-operative pain/discomfort due to less flap dissection and elevation when compared to closed flaps.
Tertiary aim is to have a histomorphometric examination and to assess the formation of new bone.
The investigators hypothesize that better bone volume percentage will be observed in closed flap technique when compared to open flap technique.
The primary outcome is the mean difference in alveolar bone height change between groups.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-resorbable membrane
Mixture of allograft mineralized cortical and cancellous chips
After extraction, the socket wound is left open to heal by secondary intention
After extraction, the socket wound is closed by primary closure
Time frame: < 6 months post extraction and ridge preservation
Models/casts will be made in stone using the impressions. A stent will be made to measure the height and width of the alveolar ridge. Ridge height will be measured before tooth extraction, and 3-5 months after ridge preservation.
Time frame: Up to 16 days post extraction and ridge preservation
Subjects will be asked to rate their pain/discomfort on a visual analog scale (VAS) questionnaire (scores on a scale of 0-10, 10 to be the worst)
Time frame: Up to 6 months post extraction and ridge preservation
Histomorphometric analysis of bone core biopsy to determine percent new bone formation
Tufts University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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