Effect of Xenogeneic Collagen Matrix on the Peri-implant Tissues of Immediate Implants.

Xenograft Model Clinical Trial

Official title:

Effect of a Volumetrically Stable Xenogeneic Collagen Matrix on the Peri-implant Tissues of Immediate Post-extraction Implants: a Randomized Controlled Clinical Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04980313
• Other study ID #: CIR-ELC-2021-01
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2021
• Est. completion date: April 2023

Study information

• Verified date: July 2021
• Source: Universitat Internacional de Catalunya
• Contact: Octavi Ortiz-Puigpelat, DDS, PhD
• Phone: +34629831138
• Email: octaviortiz[@]uic.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present clinical trial will try to demonstrate the efficacy of stable xenogeneic collagen matrix in maintaining the vestibular coronal soft tissue volume and the stabilization of mid-buccal margin position in immediate post-extraccion sockets compared with the use of autogenous connective tissue grafts.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Adequate oral hygiene (21).

2. Sufficient interocclusal space (=6 mm) to place a provisional crown without occlusion.

3. Presence of adjacent teeth. Only one tooth gap.

4. Presence of soft tissue and cortical buccal bone of the tooth to be extracted according to the classification of Elian et al. 2007

5. Adequate bone quantity in the apical region of the tooth to be extracted (assessed on the CBCT).

Exclusion Criteria:

1. Patients with medical conditions that affect bone and soft tissue metabolism.

2. Uncontrolled endocrine disorders.

3. Alcohol and drug abuse.

4. Previous history of immunodeficiency syndromes.

5. Patients who smoke> 10 cigarettes a day.

6. Active periodontal disease.

7. Absence of a tooth adjacent to the tooth to be treated.

8. Oral lesions of the untreated mucosa.

9. Recent previous history (<6 months) of local radiotherapy or chemotherapy.

10. Bruxism or severe parafunctions.

11. Pregnant patients.

Related Conditions & MeSH terms

• Xenograft Model

Intervention

Device:
• Xenogenic collagen matrix
Use of xenogenic collagen matrix for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.
• Autogenous connective tissue graft
Use of connective tissue graft for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.

Locations

Country	Name	City	State
Spain	Clinica Dental Ortiz-Puigpelat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya	Geistlich Pharma AG

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analyze the volumetric dimensional changes between the test and the control group	Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3.	At T0(initial) before extraction
Primary	Analyze the volumetric dimensional changes between the test and the control group	Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3.	At T6 (6 months after extraction)
Primary	Analyze the volumetric dimensional changes between the test and the control group	Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3.	At T12 (12 months after extraction).
Secondary	Analyze the mid-vestibular gingival level of the treated tooth.	Analyze the mid-vestibular gingival level of the treated tooth between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in milimeters.	At T0(initial) before extraction
Secondary	Analyze the mid-vestibular gingival level of the treated tooth.	Analyze the mid-vestibular gingival level of the treated tooth between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in milimeters.	At T6 (6 months after extraction)
Secondary	Analyze the mid-vestibular gingival level of the treated tooth.	Analyze the mid-vestibular gingival level of the treated tooth between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) with the use of periodontal probe in milimeters.	At T12 (12 months after extraction).
Secondary	Measure the band of keratinized tissue around the treated tooth	Measure the band of keratinized tissue around the treated tooth with the use of a periodontal probe in milimeters.	At T0(initial) before extraction
Secondary	Measure the band of keratinized tissue around the treated tooth	Measure the band of keratinized tissue around the treated tooth with the use of a periodontal probe in milimeters.	At T6 (6 months after extraction)
Secondary	Measure the band of keratinized tissue around the treated tooth	Measure the band of keratinized tissue around the treated tooth with the use of a periodontal probe in milimeters.	At T12 (12 months after extraction).
Secondary	Assessment of pain during surgery in both groups	Assessment of pain during surgery between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) using a numeric scale from 0 to 10, being 0 absence of pain and 10 worst possibble pain.	At the day of the surgery
Secondary	Assessment of pain during surgery in both groups	Assessment of pain during surgery between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) using a numeric scale from 0 to 10, being 0 absence of pain and 10 worst possibble pain.	After 10 days after surgery
Secondary	Quantification of the analgesic medication intake by patients in both groups	Quantification of the analgesic medication intake by patients in both groups after 10 days of the surgery. Type of analgesic/antiinflmatory medication and number of pills/day	At 10 days after the surgery.
Secondary	Comparison of the total surgical time used in each group.	Measure the time needed for the suergery express in: hh/mm/ss	At the day of the surgery
Secondary	Comparison of the economic costs for each patient in the collection of the autologous graft and its application versus the purchase of the Fibrogide and its application.	Comparison of the economic costs for each patient in the collection of the autologous graft and its application versus the purchase of the Fibrogide and its application. Expressed in € per each surgery.	At the day of the surgery
Secondary	Analyze patient satisfaction between groups	Analyze patient satisfaction between groups with the use of a modified Oral Health Impact Profile Questionnaire consisting of 14 questions.	At T0 before extraction.
Secondary	Analyze patient satisfaction between groups	Analyze patient satisfaction between groups with the use of a modified Oral Health Impact Profile Questionnaire consisting of 14 questions.	At T12 (12 months after the extraction).
Secondary	Analysis of possible complications in both groups.	Record the number of complications and also a descriptive analysis of the different types of complications.	They will be reported anytime during the study
Secondary	Evaluation of implant success in both groups at one year of follow-up	Evaluation of implant success in both groups at one year of follow-up, expressed in the difference in milimeters of the periimplant bone loss.	At T12 (12 months after the extraction)