N/A N=39 Randomized Single-blind Treatment

Healing Dynamics in Human Extraction Sockets Grafted With Bio-Oss Collagen®

Tooth Loss

Bottom Line

View on ClinicalTrials.gov: NCT03659617 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Number of Participants That Had an Implant That Survived 3 Years After Implant Placement — 3; 6; 7 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: xenograft (BioOss Collagen) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Iowa
Primary completion: May 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants That Had an Implant That Survived 3 Years After Implant Placement	3; 6; 7	—
SECONDARY % of Vital Bone Via Histomorphotmetric Evaluation of Bone Core Biopsies at 3 Months	—	—
SECONDARY % of Vital Bone Via Histomorphotmetric Evaluation of Bone Core Biopsies at 6 Months	—	—
SECONDARY % of Vital Bone Via Histomorphotmetric Evaluation of Bone Core Biopsies at 9 Months	—	—
SECONDARY Amount of Mineralization Via Micro-CT Analysis 3 Months	—	—
SECONDARY Amount of Mineralization Via Micro-CT Analysis 6 Months	—	—
SECONDARY Amount of Mineralization Via Micro-CT Analysis 9 Months	—	—
SECONDARY Linear Dimensional Alterations of the Alveolar Ridge From the Time of Tooth Extraction to the Time of Implant Placement (3 Months)	—	—
SECONDARY Linear Dimensional Alterations of the Alveolar Ridge From the Time of Tooth Extraction to the Time of Implant Placement (6 Months)	—	—
SECONDARY Linear Dimensional Alterations of the Alveolar Ridge From the Time of Tooth Extraction to the Time of Implant Placement (9 Months)	—	—
SECONDARY Assessment of the Mucosal Maturation of the Extraction Sites After the Use of Mucograft Seal® @ 1 Week, Using a Wound Healing Index (1-3 Scale Rating)	—	—
SECONDARY Assessment of the Mucosal Maturation of the Extraction Sites After the Use of Mucograft Seal® @ 2 Weeks, Using a Wound Healing Index (1-3 Scale Rating)	—	—
SECONDARY Assessment of the Mucosal Maturation of the Extraction Sites After the Use of Mucograft Seal® @ 6 Weeks, Using a Wound Healing Index (1-3 Scale Rating)	—	—
SECONDARY Assessment of the Mucosal Maturation Following Implant Placement, Using a Wound Healing Index (1-3 Scale Rating)	—	—
SECONDARY Patient Reported Outcomes (Pain) 1 Week Following Tooth Extraction, Using a Visual Analog Score for Pain (0-100)	—	—
SECONDARY Patient Reported Outcomes (Pain) 2 Weeks Following Tooth Extraction, Using a Visual Analog Score for Pain (0-100)	—	—
SECONDARY Patient Reported Outcomes (Pain) 6 Weeks Following Tooth Extraction, Using a Visual Analog Score for Pain (0-100)	—	—
SECONDARY Patient Reported Outcomes (Pain) 2 Weeks Following Implant Placement, Using a Visual Analog Score for Pain (0-100)	—	—
SECONDARY Patient Reported Outcomes (Patient Satisfaction), Using a Visual Analog Scale (0-100)	—	—
SECONDARY Marginal Bone Level Changes	—	—

Summary

The purpose of this study is to clinically, radiographically and histologically evaluate the healing sequence of post-extraction sockets grafted with Bio-Oss Collagen® at 3, 6 and 9 months following tooth extraction in single-rooted tooth sites. Subjects with single rooted teeth planned for extraction and replacement with endosseous dental implants will be recruited for the study based on the eligibility criteria and will be divided in three groups (Groups 1, 2 and 3).A cone-beam computed tomography (CBCT) scan will be obtained and reviewed to prepare for the surgical approach and evaluate the ridge dimensions, the tooth planned for extraction as well as the adjacent sites. After tooth extraction, the socket will be grafted with Bio-Oss Collagen® and, depending on the morphology of the extraction sockets, a collagen matrix (Mucograft® seal) and/or a restorable collagen membrane (BioGide®)will be placed to cover and stabilize the graft. Patients will return at 2 and 6 weeks post-extraction to evaluate the healing. A second CBCT will be obtained 2 weeks prior to implant placement to evaluate the ridge dimensions and compare them to the baseline data. Implant placement will take place at 12, 24 and 36 after tooth extraction for Groups 1, 2 and 3 respectively. A bone core biopsy will be obtained at the time of implant placement and will be sent for histological analysis. Patients will return for a post-operative visit at two weeks. Clinical indices (probing depth, recession, bleeding upon probing, keratinized mucosa height, plaque and gingival index), patient reported outcomes and marginal bone levels via standardized periapical radiographs will be evaluated and recorded at baseline (no more than 30 days following delivery of final implant restoration) 1, 2 and 3 years post-loading.

Eligibility Criteria

Inclusion Criteria

May be either male or female
Age: 18 years or older
Subjects with a single-rooted tooth (except mandibular incisors) indicated for extraction
Extractions socket walls should either be intact or have no more than one bony wall (buccal or lingual) dehiscence extending no more than 50% of the total bony wall height
Must be in adequate physical and mental health to undergo routine dental treatment including the surgical procedures associated tooth extraction and implant placement
Subjects' treatment plan must include replacement of the tooth to be extracted with dental implant supported fixed restoration
Subjects must have read, understood and signed an informed consent form

Exclusion Criteria

Mandibular incisors
Acute infection associated with the tooth to be extracted or with adjacent teeth
History of significant heart, stomach, liver, kidney, blood, immune system disease, or other organ impairment or systemic diseases that would prevent undergoing the proposed treatment or may result in compromised healing (e.g. poorly controlled diabetes, active heavy tobacco use [>10 cigs/day])
Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as osteoporosis, thyroid disorders or Paget's disease
Subjects taking any medication or supplement known to largely influence bone metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or chronic intake of glucocorticoids
Pregnant women or nursing mothers
Subjects that are unwilling or unable to sign the informed consent
History of lack of compliance with dental visits
Subjects unwilling to return for the required number of visits

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03659617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.