Completed

NCT Number: NCT03395145

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

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

Completed

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Key information

Conditions

Bio-Oss; Mucograft

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Health Care Campus, Dept. of Periodontology

Haifa, 31096, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal

Device

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

Primary outcomes

socket width mm

Time frame: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading
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.
alveolar height mm

Time frame: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading

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.
keratinized tissue mm

Time frame: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading

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.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study 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

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Jan 10, 2018
Registry last updated: Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.