An interventional study of Collagen Matrix 10808 and Connective tissue graft in Tooth Loss and Soft Tissue Deficiency, sponsored by Geistlich Pharma AG. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-25.
Sponsored by Geistlich Pharma AG · Not applicable, Interventional, and Treatment
The objective of this study is to investigate the safety and the function of the collagen Matrix 10808 in humans and to compare it versus the standard therapy, the transplantation of the autologous connective tissue graft. The Collagen Matrix was developed for soft tissue augmentation. It is a three dimensional porous Matrix and consists mainly of Collagen I and III.
Study patients must have a single tooth gap with insufficient soft tissue volume after implant placement. Therefore a soft tissue augmentation will be necessary.
The primary objective of this study is to assess the effectiveness of soft tissue volume augmentation procedures using the autogenous soft tissue graft or the Collagen Matrix 10808 to gain mucosal thickness. Second the safety of the two procedures will be investigated.
224 studies on the registry are indexed under Tooth Loss; 50 are open to participants now.
This study's enrollment of 20 is below the median of 30 across 166 interventional studies indexed under Tooth Loss.
Browse Tooth Loss studies →Geistlich Pharma AG is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mucosal split-thickness flap in combination with the Collagen Matrix 10808.
Device: Collagen Matrix 10808
Mucosal split-thickness flap in combination with the connective tissue graft.
Procedure: Connective tissue graft
At the day of the Intervention (day 0) sulcular incisions will be made around the neighbouring teeth and a straight incision from the lingual/palatal line angle of the distal tooth to the lingual/palatal line angle of the mesial tooth. A full thickness flap will be elevated on the lingual side, whereas a split flap will be made at the buccal aspect preparing a soft tissue pouch without the preparation of horizontal release incisions. The Collagen Matrix 10808 will then be positioned in the pouch under the elevated buccal flap. A horizontal mattress suture will be made to immobilize graft to the flap followed by four to five single sutures to close the wound.
At the day of the Intervention (day 0) sulcular incisions will be made around the neighbouring teeth and a straight incision from the lingual/palatal line angle of the distal tooth to the lingual/palatal line angle of the mesial tooth. A full thickness flap will be elevated on the lingual side, whereas a split flap will be made at the buccal aspect preparing a soft tissue pouch without the preparation of horizontal release incisions. The Connective tissue graft (Gold Standard) will then be positioned in the pouch under the elevated buccal flap. A horizontal mattress suture will be made to immobilize graft to the flap followed by four to five single sutures to close the wound.
Gain in mucosal soft tissue thickness at day 90 compared to day 0 (Baseline) value measured by trans-mucosal probing
Time frame: at day 90 compared to day 0 (Baseline)
Assessment of Adverse Events
Time frame: from Day 0 to Day 90
Closure of the wound
Time frame: at Day 7, 30, 90
Presence of Swelling
Time frame: at Day 7, 30, 90
Oral health impact profile (OHIP-G14) score
Time frame: at day 0, 7, 90
Daily Mefenaminacid consumption
Time frame: between Day 0 and Day 7
Evaluation of pain using a VAS(Visual Analogue Scale) score daily
Time frame: between Day 0 and day 7 and at Day 30 and 90
Surgery time
Time frame: at surgery
Qualitative histological assessment regarding matrix degradation and safety parameters
Time frame: at day 90
Gain in mucosal soft tissue thickness by 3D volumetric analysis
Time frame: at day 90, compared to day 0
Gain in mucosal soft tissue thickness measured by trans-mucosal probing
Time frame: at day 30 compared to day 0
Keratinized Tissue width (mm)
Time frame: at day 0 and at day 90
Probing Depth (mm)
Time frame: at day 0 and at day 90
Clinical Attachment Level (mm)
Time frame: at day 0 and at day 90
Bleeding of Probing (0/1)
Time frame: at day 0 and at day 90
Plaque Index (0-3)
Time frame: at day 0 and at day 90
Recession depth (mm)
Time frame: at day 0 and at day 90
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Geistlich Pharma AG