Bone Volume Changes After Socket Preservation Using Geistlich Bio-Oss Collagen and Mucograft Seal

NCT ID: NCT03395145

Last Updated: 2023-04-04

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-27

Study Completion Date

2022-07-17

Brief Summary

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Evaluation of Bone volume Changes after socket preservation using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal compared to natural healing after tooth extraction

Detailed Description

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In the last decade dental implants have become widely used for oral rehabilitation. But, the usage of dental Implants might be difficult in cases of alveolar bone deficiencies.

Different ridge preservation techniques were successfully used, using membrane with or without bone substitutes.new grafting material is Mucograft Seal, a collagen matrix graft, which originally used as an alternative to the connective tissue graft for the treatment of gingival recessions. Mucograft has demonstrated a good tissue reaction with high biocompatibility and a low shrinkage tendency, in order to increase the amount of keratinized gingiva in the augmented area.

Study Hypothesis: The observed changes in ridge dimensions when using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal as ridge preservation will be less pronounced in comparison to natural healing after tooth extraction.

Conditions

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Bio-Oss; Mucograft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Bio-Oss Collagen and Mucograft Seal

Bone volume Changes after socket preservation using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal

Group Type EXPERIMENTAL

Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal

Intervention Type DEVICE

Geistlich Bio-Oss® Collagen is intended to be used for filling bone defects and for bone augmentation after tooth extraction

Natural healing

Evaluation of Bone volume Changes after tooth extraction (natural healing)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal

Geistlich Bio-Oss® Collagen is intended to be used for filling bone defects and for bone augmentation after tooth extraction

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Written informed consent.
* Patients of 18 years or older.
* Patients in need of a tooth extraction in the area of premolars, canines or incisors due to periodontal and/or dental reasons, provided that the socket walls are intact (bone dehiscence of max. 4mm limited to one bone wall).
* Patients who need implant placement at the site of extraction.

Exclusion Criteria

* Inability to complete or understand the informed consent process.
* Bone dehiscence at extraction socket of more than 4 mm or 4 mm at more than one bony wall.
* Pregnant or lactating women.
* Patients who use medications that affect bone metabolism such as IV bisphosphonates.
* Heavy smokers (more than 10 cigarettes per day).
* Patients with removable prosthesis, which might compress the treated site.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eli Machtei, DMD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam Health Care Campus, Dept. of Periodontology

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0507-17-RMB CTIL

Identifier Type: -

Identifier Source: org_study_id

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