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A Prospective Study: Alveolar Ridge Augmentation Using Tenting Screws, Acellular Dermal Matrix and Combination Particulate Grafts

A Prospective Study: Alveolar Ridge Augmentation Using Tenting Screws, Acellular Dermal Matrix and Combination Particulate Grafts.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01572298
Enrollment
34
Registered
2012-04-06
Start date
2012-04-30
Completion date
2013-07-31
Last updated
2018-01-02

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

Conditions

Dental Alveolus, Oral Surgical Procedures, Preprosthetic

Brief summary

When a tooth or teeth are extracted, a defect in the bony ridge often forms. This loss of bone may make it impossible to place a dental implant. Guided bone regeneration procedures are used to re-establish a bone dimension sufficient to place a dental implant. The primary objective of the study is to determine whether there is any difference in the gain of horizontal alveolar ridge width following guided bone regeneration surgery using a combined autogenous/allogenic particulate bone graft versus a particulate allograft alone. Autogenous bone has historically been considered the gold standard for alveolar ridge grafting; however, other materials including allografts and xenografts have also been used with excellent results. This study evaluates the potential benefits, or lack thereof, for using a combined autogenous/allograft approach versus an allograft alone. The investigators will clinically evaluate the efficacy of this technique and determine the difference in bone formation between groups following healing at 5 months by observing bone growth relative to heads of the tenting screws placed horizontally in the locations of greatest defect in the alveolar ridge. A biopsy of the healed site will be taken at the time of implant placement. The null hypothesis is that there will be no difference in the amount of horizontal ridge width gain at 5 months post-grafting between the two different grafting materials (allograft alone versus allograft combined with autogenous bone). Furthermore, the null hypothesis is that histologically, the combination graft (MinerOss®/particulate autograft) will have a similar percentage of vital bone present at 5 months compared to the allograft-alone group (MinerOss®).

Detailed description

Guided bone regeneration procedures are used to re-establish a bone dimension sufficient to place a dental implant. The primary objective of the study is to determine whether there is any difference in the gain of horizontal alveolar ridge width following guided bone regeneration surgery using a combined autogenous/allogenic particulate bone graft versus a particulate allograft alone. Autogenous bone has historically been considered the gold standard for alveolar ridge grafting; however, other materials including allografts and xenografts have also been used with excellent results. This study evaluates the potential benefits, or lack thereof, for using a combined autogenous/allograft approach versus an allograft alone. The investigators will clinically evaluate the efficacy of this technique and determine the difference in bone formation between groups following healing at 5 months by observing bone growth relative to heads of the tenting screws placed horizontally in the locations of greatest defect in the alveolar ridge. A biopsy of the healed site will be taken at the time of implant placement. The null hypothesis is that there will be no difference in the amount of horizontal ridge width gain at 5 months post-grafting between the two different grafting materials (allograft alone versus allograft combined with autogenous bone). Furthermore, the null hypothesis is that histologically, the combination graft (MinerOss®/particulate autograft) will have a similar percentage of vital bone present at 5 months compared to the allograft-alone group (MinerOss®).

Interventions

DEVICEallograft alone

use of MinerOss allograft plus Alloderm GBR membrane and tenting screws

DEVICEallograft with autograft

use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws

Sponsors

The University of Texas Health Science Center at San Antonio
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* subject with a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and inadequate buccolingual dimension for dental implant placement as measured clinically and radiographically * live within catchment area of 50 mile radius from San Antonio

Exclusion criteria

* unstable systemic disease (such as compromised immune system) * patient taking steroids or other medications affecting bone metabolism * patient with history of radiation therapy to head & neck * history of previous ridge augmentation procedure or pathology at local jaw site * smokers who smoke \> 10 cigarettes per day

Design outcomes

Primary

MeasureTime frame
Gain in Horizontal Ridge Dimension5 months after surgery

Secondary

MeasureTime frame
Percentage of New Bone Formation (Histologic)5 months after surgery

Countries

United States

Participant flow

Participants by arm

ArmCount
Allograft Alone
guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material) allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws
14
Allograft Combined With Autograft
guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material) allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws
13
Total27

Baseline characteristics

CharacteristicAllograft AloneAllograft Combined With AutograftTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants2 Participants4 Participants
Age, Categorical
Between 18 and 65 years
12 Participants11 Participants23 Participants
Age, Continuous49.5 years
STANDARD_DEVIATION 11.8
47.5 years
STANDARD_DEVIATION 14.5
48.9 years
STANDARD_DEVIATION 12.6
Sex: Female, Male
Female
12 Participants11 Participants23 Participants
Sex: Female, Male
Male
2 Participants2 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 140 / 13
serious
Total, serious adverse events
0 / 140 / 13

Outcome results

Primary

Gain in Horizontal Ridge Dimension

Time frame: 5 months after surgery

ArmMeasureValue (MEAN)Dispersion
Allograft AloneGain in Horizontal Ridge Dimension3.33 gain in ridge width (mm)Standard Deviation 0.83
Allograft Combined With AutograftGain in Horizontal Ridge Dimension3.09 gain in ridge width (mm)Standard Deviation 0.63
Secondary

Percentage of New Bone Formation (Histologic)

Time frame: 5 months after surgery

Population: No data were collected for this outcome

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