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

Not Applicable

• Conditions: Xenograft Model
• Interventions: Device: Xenogenic collagen matrix; Device: Autogenous connective tissue graft

• Registration Number: NCT04980313
• Lead Sponsor: Universitat Internacional de Catalunya

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-27
• Study First Submitted: 2021-06-29
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-18
• Last Update Submitted: 2021-07-18
• Study First Posted: 2021-07-28
• Last Update Posted: 2021-07-28
• Primary Completion: 2023-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xenogenic collagen matrix	Xenogenic collagen matrix	Volumetrically stable xenogenic collagen matrix
Autogenous connective tissue graft	Autogenous connective tissue graft	Autogenous connective tissue graft obtained from the tuberosity area

Primary Outcome Measures

Name	Time	Method
Analyze the volumetric dimensional changes between the test and the control group	At T12 (12 months after extraction).	Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3.

Secondary Outcome Measures

Name	Time	Method
Analyze the mid-vestibular gingival level of the treated tooth.	At T12 (12 months after extraction).	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.
Measure the band of keratinized tissue around the treated tooth	At T12 (12 months after extraction).	Measure the band of keratinized tissue around the treated tooth with the use of a periodontal probe in milimeters.
Assessment of pain during surgery in both groups	After 10 days after surgery	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.
Quantification of the analgesic medication intake by patients in both groups	At 10 days after the surgery.	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
Comparison of the total surgical time used in each group.	At the day of the surgery	Measure the time needed for the suergery express in: hh/mm/ss
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.	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. Expressed in € per each surgery.
Analyze patient satisfaction between groups	At T12 (12 months after the extraction).	Analyze patient satisfaction between groups with the use of a modified Oral Health Impact Profile Questionnaire consisting of 14 questions.
Analysis of possible complications in both groups.	They will be reported anytime during the study	Record the number of complications and also a descriptive analysis of the different types of complications.
Evaluation of implant success in both groups at one year of follow-up	At T12 (12 months after the extraction)	Evaluation of implant success in both groups at one year of follow-up, expressed in the difference in milimeters of the periimplant bone loss.

Trial Locations

Locations (1)

Clinica Dental Ortiz-Puigpelat; 🇪🇸 Barcelona, Spain