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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed Flap Technique | Active Comparator | Healing by primary intention: Extraction and ridge preservation, utilizing non-resorbable membrane (Cytoplast® TXT-200 ) and freeze dried bone allograft (MinerOss® Cortical and Cancellous Chips (FDBA)), with flaps in primary coverage. |
|
| Open Flap Technique | Active Comparator | Healing by secondary intention: Extraction and ridge preservation, utilizing non-resorbable membrane (Cytoplast® TXT-200) and freeze dried bone allograft (MinerOss® Cortical and Cancellous Chips (FDBA)), with flaps in position for healing by secondary intention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytoplast® TXT-200 | Device | Non-resorbable membrane |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference in Alveolar Bone Height Change | 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. | < 6 months post extraction and ridge preservation |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain/Discomfort | 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) | Up to 16 days post extraction and ridge preservation |
| Percentage New Bone Formation |
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Inclusion Criteria:
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).
Exclusion Criteria:
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).
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| Name | Affiliation | Role |
|---|---|---|
| Yong Hur, DMD, MSc | TUSDM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University School of Dental Medicine | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35777057 | Derived | Aladmawy MA, Natto ZS, Kreitzer M, Ogata Y, Hur Y. Histological and histomorphometric evaluation of alveolar ridge preservation using an allograft and nonresorbable membrane with and without primary closure: A pilot randomized controlled clinical trial. Medicine (Baltimore). 2022 Jul 1;101(26):e29769. doi: 10.1097/MD.0000000000029769. | |
| 31531367 |
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Two randomization schemes were created using the statistical package R Version 2.11.1. One randomization scheme was used if the subject has more than 1 set of qualifying sites (the inclusion criteria specify bilateral sites) and randomized which set would be included in the study. The other randomization scheme was used to randomize which side is in Group 1 and which side is in Group 2. The two sites (one set) chosen to be in the study each had a 50% chance of being in either group.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants (OFT vs CFT) | Open flap technique (OFT) with secondary wound closure (test group) and closed flap technique (CFT) with primary wound closure (control group). OFT with flaps in position for healing by secondary intention CFT with flaps in primary coverage |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants (OFT vs CFT) | Open flap technique (OFT) with secondary wound closure (test group) Closed flap technique (CFT) with primary wound closure (control group). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Difference in Alveolar Bone Height Change | 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. | 20 sites were analyzed of 10 participants, 10 OFT sites and 10 CFT sites, 1 OFT and 1 CFT for each subject, were analyzed | Posted | Mean | Standard Deviation | mm | < 6 months post extraction and ridge preservation | site | site |
|
None to report during the study period, 1 year.
Adverse events were recorded in source documents and on case report forms. All adverse events and non-serious situations were recorded, monitored, and reported to the IRB at the time of continuing review or at the study's termination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Flap Technique (OFT) | Open flap technique (OFT, test group) with secondary wound closure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yong Hur | Tufts University | 6176366531 | Yong.Hur@tufts.edu |
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| MinerOss® Cortical and Cancellous Chips (FDBA) | Device | Mixture of allograft mineralized cortical and cancellous chips |
|
| Open Flap Technique | Procedure | After extraction, the socket wound is left open to heal by secondary intention |
|
| Closed Flap Technique | Procedure | After extraction, the socket wound is closed by primary closure |
|
Histomorphometric analysis of bone core biopsy to determine percent new bone formation |
| Up to 6 months post extraction and ridge preservation |
| Aladmawy MA, Natto ZS, Steffensen B, Levi P, Cheung W, Finkelman M, Ogata Y, Hur Y. A Comparison between Primary and Secondary Flap Coverage in Ridge Preservation Procedures: A Pilot Randomized Controlled Clinical Trial. Biomed Res Int. 2019 Aug 20;2019:7679319. doi: 10.1155/2019/7679319. eCollection 2019. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| site |
|
|
| Secondary | Post-operative Pain/Discomfort | 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) | 10 subject received CFT and OFT simultaneously. Post-operative pain/discomfort comparing the two techniques were analyzed | Posted | Mean | Standard Deviation | VAS(scale 0-10), scores on a scale | Up to 16 days post extraction and ridge preservation |
|
|
|
| Secondary | Percentage New Bone Formation | Histomorphometric analysis of bone core biopsy to determine percent new bone formation | 16 sites were analyzed of 8 participants, 8 OFT sites and 8 CFT sites were analyzed | Posted | Mean | Standard Deviation | percentage of new bone formation | Up to 6 months post extraction and ridge preservation | site | site |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Closed Flap Technique (CFT) | closed flap technique (CFT, control group) with primary wound closure | 0 | 10 | 0 | 10 | 0 | 10 |
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