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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Xenograft Model
• Intervention / Treatment: Device: Xenogenic collagen matrix; Device: Autogenous connective tissue graft

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Octavi Ortiz-Puigpelat, DDS, PhD; Phone Number: +34629831138; Email: octaviortiz@uic.es

Study Locations

• Spain
  • Barcelona, Spain, 08028
    • Recruiting
    • Clinica Dental Ortiz-Puigpelat
    • Contact: Octavi Ortiz-Puigpelat; Phone Number: +34629831138; Email: octavi_ortiz@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Xenogenic collagen matrix; Volumetrically stable xenogenic collagen matrix	Device: Xenogenic collagen matrix; Use of xenogenic collagen matrix for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.
ACTIVE_COMPARATOR: Autogenous connective tissue graft; Autogenous connective tissue graft obtained from the tuberosity area	Device: Autogenous connective tissue graft; Use of connective tissue graft for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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).
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
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)
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).
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
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
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.
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
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
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.
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).
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
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)

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya
• Collaborators: Geistlich Pharma AG

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 27, 2021
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): April 1, 2023

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: July 18, 2021
• First Posted (ACTUAL): July 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 18, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: connective tissue graft; dental extraction; alveolar socket; immediate dental implants; xenogenic collagen matrix
• Other Study ID Numbers: CIR-ELC-2021-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No