Trial Outcomes & Findings for Efficacy of Socket Grafting for Alveolar Ridge Preservation (NCT NCT01794806)

NCT ID: NCT01794806

Last Updated: 2017-08-17

Results Overview

3D reconstructions using radiographic data obtained at baseline and at 14 weeks after the intervention was utilized to calculate the reduction of bone volume that took place during the healing period in both groups

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 59 participants
• Primary outcome timeframe: Baseline to Week 14 after tooth extraction
• Results posted on: 2017-08-17

Participant Flow

Participant milestones

Measure	Tooth Extraction and Grafting Tooth extraction and grafting with allograft Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane	Tooth Extraction Tooth extraction Tooth extraction: Minimally traumatic single-rooted tooth extraction
Overall Study STARTED	31	28
Overall Study 1 Week	28	28
Overall Study 4 Weeks	26	27
Overall Study COMPLETED	26	27
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Socket Grafting for Alveolar Ridge Preservation

Baseline characteristics by cohort

Measure	Tooth Extraction and Grafting n=31 Participants Tooth extraction and grafting with allograft Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane	Tooth Extraction n=28 Participants Tooth extraction Tooth extraction: Minimally traumatic single-rooted tooth extraction	Total n=59 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	58.46 years STANDARD_DEVIATION 12.37 • n=5 Participants	57.24 years STANDARD_DEVIATION 11.82 • n=7 Participants	57.84 years STANDARD_DEVIATION 11.99 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	28 participants n=7 Participants	59 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 14 after tooth extraction

3D reconstructions using radiographic data obtained at baseline and at 14 weeks after the intervention was utilized to calculate the reduction of bone volume that took place during the healing period in both groups

Outcome measures

Measure	Tooth Extraction and Grafting n=26 Participants Tooth extraction and grafting with allograft Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane	Tooth Extraction n=27 Participants Tooth extraction Tooth extraction: Minimally traumatic single-rooted tooth extraction
Alveolar Ridge Volumetric Changes	-8.36 percentage of volume change Standard Deviation 3.81	-15.83 percentage of volume change Standard Deviation 4.48

SECONDARY outcome

Timeframe: Baseline to Week 14 after tooth extraction

Linear ridge width change at the bone crest

Outcome measures

Measure	Tooth Extraction and Grafting n=26 Participants Tooth extraction and grafting with allograft Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane	Tooth Extraction n=27 Participants Tooth extraction Tooth extraction: Minimally traumatic single-rooted tooth extraction
Changes in Bucco-lingual Ridge Dimension	-1.0 millimeters Interval -1.49 to -0.64	-1.8 millimeters Interval -2.1 to -1.26

SECONDARY outcome

Timeframe: Week 14 after tooth extraction

Linear ridge height change at the mid-facial aspect of the ridge

Outcome measures

Measure	Tooth Extraction and Grafting n=26 Participants Tooth extraction and grafting with allograft Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane	Tooth Extraction n=27 Participants Tooth extraction Tooth extraction: Minimally traumatic single-rooted tooth extraction
Changes in Apico-coronal Ridge Dimension	-0.61 millimeters Interval -0.94 to -0.46	-1.17 millimeters Interval -2.1 to -0.7

Adverse Events

Tooth Extraction and Grafting

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tooth Extraction

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tooth Extraction and Grafting n=31 participants at risk Tooth extraction and grafting with allograft Tooth extraction and grafting with allograft: Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane	Tooth Extraction n=28 participants at risk Tooth extraction Tooth extraction: Minimally traumatic single-rooted tooth extraction
Infections and infestations Dry Alveolitis	0.00% 0/31	7.1% 2/28 • Number of events 2

Additional Information

Gustavo Avila-Ortiz

University of Iowa

Phone: 3193357241

Email: gustavo-avila@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place