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

Bio-Oss; Mucograft Clinical Trial

Official title:

Valuation of Bone Volume Changes After Socket Preservation Using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal Compared to Natural Healing After Tooth Extraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395145
• Other study ID #: 0507-17-RMB CTIL
• Status: Completed
• Phase: N/A
• Start date: May 27, 2018
• Est. completion date: July 17, 2022

Study information

• Verified date: April 2023
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 17, 2022
• Est. primary completion date: July 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bio-Oss; Mucograft

Intervention

Device:
• 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

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus, Dept. of Periodontology	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	socket width mm	The socket width (buccal-lingual aspect) will be assessed at the following reference points: 3-(?ACH pre-post) millimeters apical to the alveolar crest, where the buccal and lingual walls are intact.; 5-(?ACH pre-post) millimeters apical to the alveolar crest, where the buccal and lingual walls are intact.; The width of each cortical buccal and lingual bone plate, 3 millimeters apical to the alveolar crest.; The width of each cortical buccal and lingual bone plate, 5 millimeters apical to the alveolar crest.	baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading
Primary	alveolar height mm	Alveolar crest height (ACH) will be measured from the apical part of the stent to the bone crest at the mid M-D distance of the socket.	baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading
Primary	keratinized tissue mm	In the lower jaw the keratinized tissue width will be measured from the apical part of the stent to the mucogingival line on the buccal and lingual sides. On the upper jaw only the keratinized tissue on the buccal side will be measured.	baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading