Alveolar ridge preservation with a xenograft Bio-Oss Collagen) and a collagen matrix (Mucograft Seal) or a free connective tissue graft versus spontaneous healing: a 1-year prospective randomized clinical study

Alveolar ridge preservation with a xenograft Bio-Oss Collagen) and a collagen matrix (Mucograft Seal) or a free connective tissue graft versus spontaneous healing: a 1-year prospective randomized clinical study - Mucograft Seal

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42186

Enrollment

Registered

2015-06-23

Start date

2015-01-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

soft tissue defect

Interventions

In the current prospective randomized clinical study, patients are assigned to one of three socket seal techniques: A) Placement of a bone substitute material (demineralized bovine bone mineral wit

Bio-Oss Collagen®, Geistlich) covered with a collagen matrix (Geistlich Mucograft® Seal). B) Placement of a bone substitute material (demineralized bovine bone mineral with 10% collagen

Bio-Oss Collagen®, Geistlich) covered with a punch biopsy of the palate. C) Spontaneous healing (control group).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Over 18 years of age 2) Need for an implant-supported crown to replace a maxillary tooth at the location of an incisor, cupsid or first/second bicuspid 3) Single tooth diastema as a maximum 4) Intact buccal bone 5) Sufficient occlusal and mesio-distal dimensions for insertion of one implant with a functional prosthetic restoration.

Exclusion criteria

Exclusion criteria: 1) Presence of clinical active periodontal disease. 2) Presence of an acute inflammatory oral disease. 3) Smoking. 4) Diabetes. 5) A history of radiotherapy in the head-and-neck region or current chemotherapy 6) Disability (mental and/or physical) to maintain basic oral hygiene procedures. 7) Under eighteen years of age

Design outcomes

Primary

Measure	Time frame
The level of the buccal marginal gingiva.	—

Secondary

Measure	Time frame
1. Peri-implant esthetic score (PES) 2. White esthetic score (WES) 3. Labial soft tissue volume (using impressions) 4. The marginal bone level around the implants/ Distance from implant shoulder to first bone-to-implant contact (MBL/DIB) using a standardized digital intra-oral radiograph 5. Evaluation of facial bone wall (using CBCT) 6. The plaque index (PI) 7. The bleeding index (B) 8. The gingiva index (GI) 9. The pocket probing depth (PPD) 10. The width of the attached mucosa (WAM) 11. Patient*s satisfaction about the esthetical result of the crown and peri-implant tissue	—

Measure

Time frame

1. Peri-implant esthetic score (PES) 2. White esthetic score (WES) 3. Labial soft tissue volume (using impressions) 4. The marginal bone level around the implants/ Distance from implant shoulder to first bone-to-implant contact (MBL/DIB) using a standardized digital intra-oral radiograph 5. Evaluation of facial bone wall (using CBCT) 6. The plaque index (PI) 7. The bleeding index (B) 8. The gingiva index (GI) 9. The pocket probing depth (PPD) 10. The width of the attached mucosa (WAM) 11. Patient*s satisfaction about the esthetical result of the crown and peri-implant tissue

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)