Trial Outcomes & Findings for Healing Dynamics in Human Extraction Sockets Grafted With Bio-Oss Collagen® (NCT NCT03659617)

Results Overview

For participants that had implant placement, this outcome is determined via clinical evaluation of the number of participants that still had their 1 implant in place after 3 Years. Note: Only 1 implant was placed per participant.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

3 years after implant placement

Results posted on

2026-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	Implant Placement 3 Months After Tooth Extraction Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)	Implant Placement 6 Months After Tooth Extraction Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)	Implant Placement 9 Months After Tooth Extraction Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)
Overall Study STARTED	12	14	13
Overall Study COMPLETED	3	6	7
Overall Study NOT COMPLETED	9	8	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Implant Placement 3 Months After Tooth Extraction n=12 Participants Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)	Implant Placement 6 Months After Tooth Extraction n=14 Participants Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)	Implant Placement 9 Months After Tooth Extraction n=13 Participants Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)	Total n=39 Participants Total of all reporting groups
Region of Enrollment United States	12 participants n=12 Participants	14 participants n=14 Participants	13 participants n=13 Participants	39 participants n=39 Participants
Age, Categorical <=18 years	0 Participants n=12 Participants	0 Participants n=14 Participants	0 Participants n=13 Participants	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=12 Participants	8 Participants n=14 Participants	8 Participants n=13 Participants	23 Participants n=39 Participants
Age, Categorical >=65 years	5 Participants n=12 Participants	6 Participants n=14 Participants	5 Participants n=13 Participants	16 Participants n=39 Participants
Sex: Female, Male Female	7 Participants n=12 Participants	8 Participants n=14 Participants	6 Participants n=13 Participants	21 Participants n=39 Participants
Sex: Female, Male Male	5 Participants n=12 Participants	6 Participants n=14 Participants	7 Participants n=13 Participants	18 Participants n=39 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 3 years after implant placement

For participants that had implant placement, this outcome is determined via clinical evaluation of the number of participants that still had their 1 implant in place after 3 Years. Note: Only 1 implant was placed per participant.

Outcome measures

Outcome measures
Measure	Implant Placement 3 Months After Tooth Extraction n=7 Participants Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)	Implant Placement 6 Months After Tooth Extraction n=9 Participants Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)	Implant Placement 9 Months After Tooth Extraction n=9 Participants Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)
Number of Participants That Had an Implant That Survived 3 Years After Implant Placement	3 participants	6 participants	7 participants

SECONDARY outcome

Timeframe: 3 months

% of vital bone

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

% of vital bone

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

% of vital bone

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Amount of mineralization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Amount of mineralization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Amount of mineralization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Clinical and radiographic (via CBCT) assessment. The buccal - lingual ridge width at the time of the extraction will be measured clinically using a periodontal probe (UNC-15) and prior to implant placement (3-months). The same measurements will be performed radiographically through the CBCTs taken prior to tooth extraction and prior to implant placement, utilizing a CBCT viewer software. The linear vertical alterations will be used utilizing the same methods, using fiduciary anatomical landmarks. Superimposition of the digital files obtained from the intra-oral scanner will be utilized to verify these changes clinically.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Clinical and radiographic (via CBCT) assessment. The buccal - lingual ridge width at the time of the extraction will be measured clinically using a periodontal probe (UNC-15) and prior to implant placement (6-months). The same measurements will be performed radiographically through the CBCTs taken prior to tooth extraction and prior to implant placement, utilizing a CBCT viewer software. The linear vertical alterations will be used utilizing the same methods, using fiduciary anatomical landmarks. Superimposition of the digital files obtained from the intra-oral scanner will be utilized to verify these changes clinically.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Clinical and radiographic (via CBCT) assessment. The buccal - lingual ridge width at the time of the extraction will be measured clinically using a periodontal probe (UNC-15) and prior to implant placement (9-months). The same measurements will be performed radiographically through the CBCTs taken prior to tooth extraction and prior to implant placement, utilizing a CBCT viewer software. The linear vertical alterations will be used utilizing the same methods, using fiduciary anatomical landmarks. Superimposition of the digital files obtained from the intra-oral scanner will be utilized to verify these changes clinically.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 week following tooth extraction and alveolar ridge preservation

Wound Healing Index. 1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks following tooth extraction and alveolar ridge preservation

Wound Healing Index.1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks following tooth extraction and alveolar ridge preservation

Wound Healing Index. 1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks following dental implant placement

Wound Healing Index. 1-3 scale rating: 1) Uneventful Healing, 2) Normal healing with moderate soft tissue inflammation, erythema but no suppuration and 3) poor wound healing with significant signs of clinical inflammation and/or suppuration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 week following tooth extraction and alveolar ridge preservation

Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks following tooth extraction and alveolar ridge preservation

Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks following tooth extraction and alveolar ridge preservation

Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks following implant placement

Visual Analog Score for pain (0-100, with 0 representing no pain, and 100 very severe pain, described as "worse pain imaginable").

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 days post implant crown delivery

The patients will be asked to rate their satisfaction in terms of function, comfort and esthetics, using a Visual Analog Scale (0-100, with 0 meaning "not at satisfied at all" and 100 corresponding to "perfectly satisfied").

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years post implant crown delivery

measured in mm based on standardized intro-oral radiographs

Outcome measures

Outcome data not reported

Adverse Events

Implant Placement 3 Months After Tooth Extraction

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Implant Placement 6 Months After Tooth Extraction

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Implant Placement 9 Months After Tooth Extraction

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Implant Placement 3 Months After Tooth Extraction n=12 participants at risk Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 months after tooth extraction xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)	Implant Placement 6 Months After Tooth Extraction n=14 participants at risk Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 months after tooth extraction xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)	Implant Placement 9 Months After Tooth Extraction n=13 participants at risk Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 months after tooth extraction xenograft (BioOss Collagen): Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)
Product Issues Implant Failure	33.3% 4/12 • 3 Years	21.4% 3/14 • 3 Years	15.4% 2/13 • 3 Years

Additional Information

Carlos Garaicoa Pazmino, DDS, MS

University of Iowa

Phone: (319) 467-4315

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place