Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix

NCT ID: NCT05081284

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2025-11-30

Brief Summary

The purpose of this study is to evaluate the soft tissue clinical results in patients that received, or not, a soft tissue augmentation around dental implant inserted immediately after the extraction.

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determinate eligibility for study entry. Patients who meet eligibility requirements will be randomized in this single blinded(investigator) study.

Group (Test) will receive immediate implant after extraction and a soft tissue augmentation with a collagen matrix.

Group (Control) will receive only immediate implant after extraction without soft tissue augmentation.

Conditions

Edentulous Alveolar Ridge

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Immediate implant insertion in fresh-extraction site, will be performed. Peri-implant bone defect will be grafted with a deproteinized bovine bone mineral with 10% collagen and covered with a collagen matrix. After the surgical procedures, each implant will receive a healing abutment until prosthetic restorative procedures.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Test Group

Immediate implant insertion in fresh-extraction site, will be performed. Peri-implant bone defect will be grafted with a deproteinized bovine bone mineral with 10% collagen and covered with a collagen matrix, and then a volume-stable collagen matrix will be buccally inserted with a split-thickness flap preparation. Subsequently, the collagen matrix graft will be stabilized with a horizontal mattress suture to the buccal flap. After the surgical procedures, each implant will receive healing abutment connection until the prosthetic restorative procedures

Group Type: EXPERIMENTAL

Volume-stable collagen matrix Geistlich Fibro-Gide®

Intervention Type: DEVICE

After tooth extraction and implant insertion the Test group will receive a soft tissue augmentation on the buccal side oh the implant. an envelop flap will be raised and a volume-stable collagen graft will be stabilized with sutures.

Control group will not receive soft tissue augmentation.

Interventions

Volume-stable collagen matrix Geistlich Fibro-Gide®

After tooth extraction and implant insertion the Test group will receive a soft tissue augmentation on the buccal side oh the implant. an envelop flap will be raised and a volume-stable collagen graft will be stabilized with sutures.

Control group will not receive soft tissue augmentation.

Intervention Type: DEVICE

Other Intervention Names

Geistlich Fibro-Gide, G1 039446 0086 Rev. 00 G7 16 07 39446 073

Eligibility Criteria

Inclusion Criteria

• Presence of a single failing tooth in the esthetic region (second premolar to contralateral second premolar), the adjacent teeth should be present and without any dental pathologies.

Exclusion Criteria

• Patients who are heavy smokers (more than 10 cigarettes/day);
• Patients who suffer from any systemic diseases that could negatively influence wound healing;
• Patients who received head and neck radiation treatment;
• Patients who have a full contraindication to implant surgery;
• Patients who have uncontrolled periodontal disease;
• Patients who show a full mouth plaque and bleeding score higher than 25%;
• Patients who have deficient extraction sockets according to the classification of Juodzbalys et al. 2008.
• Patients with known allergy, sensitivity or intolerance to collagen
• Patients who are pregnant or who are breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Antonio Barone

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Barone, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Pisa

Locations

U.O. Odontostomatologia e Chirurgia del Cavo Orale

Pisa, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Antonio Barone, DDS

Role: CONTACT

antonio.barone@unipi.it

050993327

Facility Contacts

Antonio Barone, Professor

Role: primary

antonio.barone@unipi.it

050993327

References

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Reference Type: RESULT

PMID: 28548210 (View on PubMed)

Bittner N, Planzos L, Volchonok A, Tarnow D, Schulze-Spate U. Evaluation of Horizontal and Vertical Buccal Ridge Dimensional Changes After Immediate Implant Placement and Immediate Temporization With and Without Bone Augmentation Procedures: Short-Term, 1-Year Results. A Randomized Controlled Clinical Trial. Int J Periodontics Restorative Dent. 2020 Jan/Feb;40(1):83-93. doi: 10.11607/prd.4152.

Reference Type: RESULT

PMID: 31815977 (View on PubMed)

Zeltner M, Jung RE, Hammerle CH, Husler J, Thoma DS. Randomized controlled clinical study comparing a volume-stable collagen matrix to autogenous connective tissue grafts for soft tissue augmentation at implant sites: linear volumetric soft tissue changes up to 3 months. J Clin Periodontol. 2017 Apr;44(4):446-453. doi: 10.1111/jcpe.12697. Epub 2017 Feb 11.

Reference Type: RESULT

PMID: 28107560 (View on PubMed)

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Pjetursson BE, Thoma D, Jung R, Zwahlen M, Zembic A. A systematic review of the survival and complication rates of implant-supported fixed dental prostheses (FDPs) after a mean observation period of at least 5 years. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:22-38. doi: 10.1111/j.1600-0501.2012.02546.x.

Reference Type: RESULT

PMID: 23062125 (View on PubMed)

van der Meulen MJ, Lobbezoo F, John MT, Naeije M. [Oral health impact profile. an instrument for measuring the impact of oral health on the quality of life]. Ned Tijdschr Tandheelkd. 2011 Mar;118(3):134-9. doi: 10.5177/ntvt.2011.03.10178. Dutch.

Reference Type: RESULT

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Other Identifiers

19228

Identifier Type: -

Identifier Source: org_study_id