Novel Porous Bioceramic Material as a Bone Substitute

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-01-27

Brief Summary

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The aim of this study is to demonstrate that new synthetic bone graft bioceramic composites (Adaptos®-Si and Adaptos®, Biomendex Oy) are able to support the preservation of the alveolar ridge and to promote bone regeneration following dental extraction. New bone graft substitutes are compared with already existing treatment principles used following dental extraction.

The primary hypothesis of the study is that Adaptos®-Si granules can reach a clinical outcome superior to that of dental socket left empty after extraction. Secondary aim is that new bioceramic composites can reach a clinical outcome non inferior to the active comparator of this study (Geistlisch Bio-Oss®).

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Detailed Description

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The purpose of this study is to evaluate new synthetic Adaptos®-Si and Adaptos® in ridge preservation bone grafting after dental extraction. This is partly randomized, subject and outcome assessor-blinded, controlled, single center study. The total study duration for each patient is planned to be 10 months. In total 4 visits per patient are scheduled in this study.

Subjects will undergo a single tooth extraction and then will be randomized to receive one of the four bone graft substitutes, which are Adaptos®-Si (one of the the two granula sizes), Adaptos®, or Geistlich Bio-Oss®. Gelatin sponge is applied on the bone graft filled extraction socket. Non-randomized part of the study includes the patients that have chosen the conservative treatment option with dental socket left empty and no intention for dental implant placement. Following a healing period of 5 months, a dental implant will be placed, unless the patient has chosen the empty socket. The subject will be followed for ten months following tooth extraction. Bone ridge horizontal and vertical change assessment will be done by CBCT (primary and secondary outcome) at the time of tooth extraction, and 5 months and 10 months post-extraction.

The study device Bio-Oss® (Geistlich Pharma) and Spongostan Absorbable Haemostatic Gelatin Sponge (Ferrosan Medical Devices) are CE-marked. The products are used within the indication.

Conditions

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Alveolar Ridge Preservation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Adaptos-Si [0.5-1 mm]

Bone augmentation, after tooth extraction, with Adaptos-Si \[0.5-1 mm\] (synthetic bone graft material) in combination with a gelatin sponge.

Group Type EXPERIMENTAL

Adaptos®-Si [0.5-1 mm] (bone grafting surgery)

Intervention Type DEVICE

After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.

Adaptos-Si [1-2 mm]

Bone augmentation, after tooth extraction, with Adaptos-Si \[1-2 mm\] (synthetic bone graft material) in combination with a gelatin sponge.

Group Type EXPERIMENTAL

Adaptos®-Si [1-2 mm] (bone grafting surgery)

Intervention Type DEVICE

After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.

Bio-Oss

Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft) in combination with a gelatin sponge.

Group Type ACTIVE_COMPARATOR

Geistlich Bio-Oss (bone grafting surgery)

Intervention Type DEVICE

After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.

Empty extraction socket

Post-extraction the socket filled only by clot.

Group Type PLACEBO_COMPARATOR

Tooth extraction without bone graft material

Intervention Type PROCEDURE

After screening and enrollment, subjects will undergo tooth extraction of a single tooth and the socket is filled only by clot. Subject will be followed at 2 weeks, 5 months, and 10 months for healing.

Adaptos [1-2 mm]

Bone augmentation, after tooth extraction, with Adaptos \[1-2 mm\] (synthetic bone graft material) in combination with a gelatin sponge.

Group Type EXPERIMENTAL

Adaptos® (bone grafting surgery)

Intervention Type DEVICE

After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.

Interventions

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Adaptos®-Si [0.5-1 mm] (bone grafting surgery)

After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.

Intervention Type DEVICE

Adaptos®-Si [1-2 mm] (bone grafting surgery)

After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.

Intervention Type DEVICE

Geistlich Bio-Oss (bone grafting surgery)

After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.

Intervention Type DEVICE

Tooth extraction without bone graft material

After screening and enrollment, subjects will undergo tooth extraction of a single tooth and the socket is filled only by clot. Subject will be followed at 2 weeks, 5 months, and 10 months for healing.

Intervention Type PROCEDURE

Adaptos® (bone grafting surgery)

After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.

Intervention Type DEVICE

Other Intervention Names

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Ridge preservation bone grafting after tooth extraction. Ridge preservation bone grafting after tooth extraction. Ridge preservation bone grafting after tooth extraction. Ridge preservation bone grafting after tooth extraction.

Eligibility Criteria

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Inclusion Criteria

* Patient must have voluntarily signed the informed consent
* Females and males, 18 years to 80 years of age
* Patient needs single tooth extraction of 1st or 2nd premolar or molar tooth
* At least one adjacent teeth present
* At least 3 intact walls
* Subjects must be committed to the study and the required follow-up visits

Exclusion Criteria

* Planned radiation or radiation during previous year in the tooth extraction area.
* Smoking
* Osteoporosis
* Uncontrolled periodontitis
* Alcohol or drug abuse
* Pregnant or breastfeeding women
* Uncontrolled diabetes
* Local acute or chronic infection or presence of oral lesions or trauma
* Immunosuppressive disease, treatment, or medication
* Subject is part of the investigator team of this study or investigator's family member
* Subject is employee of one of the organizations involve in this study

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No