Clinical trial NCT04980313: Effect of Xenogeneic Collagen Matrix on the Peri-implant Tissues of Immediate Implants.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Xenograft Model
Keywords: immediate dental implants
dental extraction
alveolar socket
connective tissue graft
xenogenic collagen matrix
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
Collaborators: name: Geistlich Pharma AG
First posted: 2021-07-28
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Analyze the volumetric dimensional changes between the test and the control group
timeFrame: At T0(initial) before extraction
measure: Analyze the volumetric dimensional changes between the test and the control group
timeFrame: At T6 (6 months after extraction)
measure: Analyze the volumetric dimensional changes between the test and the control group
timeFrame: At T12 (12 months after extraction).
Secondary outcomes:
measure: Analyze the mid-vestibular gingival level of the treated tooth.
timeFrame: At T0(initial) before extraction
measure: Analyze the mid-vestibular gingival level of the treated tooth.
timeFrame: At T6 (6 months after extraction)
measure: Analyze the mid-vestibular gingival level of the treated tooth.
timeFrame: At T12 (12 months after extraction).
measure: Measure the band of keratinized tissue around the treated tooth
timeFrame: At T0(initial) before extraction
measure: Measure the band of keratinized tissue around the treated tooth
timeFrame: At T6 (6 months after extraction)
measure: Measure the band of keratinized tissue around the treated tooth
timeFrame: At T12 (12 months after extraction).
measure: Assessment of pain during surgery in both groups
timeFrame: At the day of the surgery
measure: Assessment of pain during surgery in both groups
timeFrame: After 10 days after surgery
measure: Quantification of the analgesic medication intake by patients in both groups
timeFrame: At 10 days after the surgery.
measure: Comparison of the total surgical time used in each group.
timeFrame: At the day of the surgery
measure: 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.
timeFrame: At the day of the surgery
measure: Analyze patient satisfaction between groups
timeFrame: At T0 before extraction.
measure: Analyze patient satisfaction between groups
timeFrame: At T12 (12 months after the extraction).
measure: Analysis of possible complications in both groups.
timeFrame: They will be reported anytime during the study
measure: Evaluation of implant success in both groups at one year of follow-up
timeFrame: At T12 (12 months after the extraction)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Clinica Dental Ortiz-Puigpelat
Study officials:
References: