Skip to content

An Assessment of Bone Augmentation in Post-Extraction Sockets

A Prospective Study of Bone Augmentation Techniques in Extraction Sockets and Implant Surface Textures

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00641316
Acronym
FMD-007
Enrollment
41
Registered
2008-03-24
Start date
2008-04-30
Completion date
2012-11-30
Last updated
2024-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Extraction Sockets, Unrestorable Dentition

Keywords

Freeze-dried bone allograft, Platelet-rich plasma, Platelet-derived growth factors, Laser-threaded dental implants, Resorbable blast textured dental implants

Brief summary

When a tooth is extracted the ridge of bone that held the tooth in place begins to heal and over time new bone grows to fill the empty space left by the missing tooth. Sometimes this process works very well and new bone grows to completely fill the socket, at other times new bone fails to fill in the space completely and patients are left with uneven bone-fill. Grafted extraction sockets may fill with bone faster and more evenly than those without grafts, allowing the dentist to have greater control over the healing process and to repair the area with dental implants in a shorter period of time. This study will help determine if grafting an extraction socket, with or without enriching the graft material, is an added benefit when compared to allowing the socket to heal naturally. The study will also assess how well two different dental implant designs used to restore the area will function over time.

Detailed description

Tooth extraction is often associated with resorption of the alveolar ridge height and width and with compromised soft tissue contours. A variety of methods have been proposed to overcome varied patterns of post-extraction healing. An increasingly common practice combines skilled surgical technique with post-extraction site grafting utilizing both natural and synthetic bone-graft materials. These procedures are thought to retard resorption of the socket volume while lending some control over bone-fill - thereby preserving the integrity of the alveolar ridge for future reconstruction with dental implants. Limited evidence-based data exist to support a variety of bone-graft materials including grafts enriched with autologous platelet-rich plasma(PRP)and grafts enriched with recombinant human platelet-derived growth factors(PDGF). Despite emerging clinical acceptance the most efficacious intervention remains undetermined. In an effort to establish clinical evidence, this study will assess the efficacy of ridge preservation using three different bone grafting applications in post-extraction sockets compared to extraction alone. The study will also asses longitudinal success of restoring the study sites with dental implants. Two innovative dental implant designs will be used in the study; an implant with a resorbable blast textured(RBT)surface and an implant with a laser thread-textured (LTT)surface.

Interventions

PROCEDUREAtraumaticTeeth Extraction

Teeth extraction alone, allowed to heal for 2 months followed by implant therapy to the sites

PROCEDUREAtraumatic Teeth Extraction/Grafted Extraction Sockets

Teeth extraction/post-extraction socket grafting with Freeze-Dried Bone Allograft (FDBA) mixed with Tri-Calcium Phosphate(TCP) allowed to heal for 2 months followed by dental implant therapy to the sites

Sponsors

BioHorizons, Inc.
CollaboratorINDUSTRY
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Needed extraction of Maxillary and/or Mandibular Incisors and/or Pre-molar teeth

Exclusion criteria

* Inability to provide informed consent in English * Pregnant women

Design outcomes

Primary

MeasureTime frameDescription
Bone-fill in Grafted Post-extraction Sockets Versus Bone-fill in Non-grafted Post-extraction Sockets2 monthsNew bone formation in grafted extraction sockets to that of sites healed after 8 weeks of post-extraction.

Countries

United States

Participant flow

Recruitment details

Randomization was performed by site (teeth) in the mouth. Each participant has only one tooth enrolled in the study.

Participants by arm

ArmCount
1 Atraumatic Teeth Extraction
Teeth extraction followed by natural healing AtraumaticTeeth Extraction: Teeth extraction alone, allowed to heal for 2 months followed by implant therapy to the sites
9
2- FDBA/TCP
Atraumatic Teeth Extraction/Grafted Extraction Sockets: Teeth extraction/post-extraction socket grafting with Freeze-Dried Bone Allograft (FDBA) mixed with Tri-Calcium Phosphate(TCP) allowed to heal for 2 months followed by dental implant therapy to the sites
11
3 FDBA/TCP+PRP
Atraumatic Teeth Extraction/Grafted Extraction Sockets: Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Autologous Platelet-Rich Plasma (PRP) allowed to heal for 2 months followed by dental implant therapy to the sites
12
4 FDBA/TCP + PDGF
Atraumatic Teeth Extraction/Grafted Extraction Sockets: Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Platelet-Derived Growth Factors (PDGF) allowed to heal for 2 months followed by dental implant therapy to the sites
9
Total41

Baseline characteristics

Characteristic2- FDBA/TCP3 FDBA/TCP+PRP1 Atraumatic Teeth Extraction4 FDBA/TCP + PDGFTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants1 Participants2 Participants3 Participants9 Participants
Age, Categorical
Between 18 and 65 years
8 Participants11 Participants7 Participants6 Participants32 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
3 Participants1 Participants1 Participants1 Participants6 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
White
7 Participants10 Participants8 Participants8 Participants33 Participants
Sex: Female, Male
Female
9 Participants9 Participants5 Participants6 Participants29 Participants
Sex: Female, Male
Male
2 Participants3 Participants4 Participants3 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 110 / 120 / 9
other
Total, other adverse events
0 / 90 / 110 / 120 / 9
serious
Total, serious adverse events
0 / 90 / 110 / 120 / 9

Outcome results

Primary

Bone-fill in Grafted Post-extraction Sockets Versus Bone-fill in Non-grafted Post-extraction Sockets

New bone formation in grafted extraction sockets to that of sites healed after 8 weeks of post-extraction.

Time frame: 2 months

Population: Each participant has only one tooth enrolled.

ArmMeasureValue (MEAN)Dispersion
1 Atraumatic Teeth ExtractionBone-fill in Grafted Post-extraction Sockets Versus Bone-fill in Non-grafted Post-extraction Sockets0.43 mmStandard Deviation 0.24
2- FDBA/TCPBone-fill in Grafted Post-extraction Sockets Versus Bone-fill in Non-grafted Post-extraction Sockets0.27 mmStandard Deviation 0.07
3 FDBA/TCP+PRPBone-fill in Grafted Post-extraction Sockets Versus Bone-fill in Non-grafted Post-extraction Sockets0.36 mmStandard Deviation 0.15
4 FDBA/TCP + PDGFBone-fill in Grafted Post-extraction Sockets Versus Bone-fill in Non-grafted Post-extraction Sockets0.28 mmStandard Deviation 0.09

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026