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

NCT05081284 | Active Not Recruiting DMC

• 1 other identifier: 19228
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous Alveolar Ridge

Keywords

Soft tissue augmentation; Immediate implant; Collagen matrix

Outcome Measures

Primary Outcomes (3)

• Soft Tissue Thickness (STT)

  Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)

  T0a: baseline before surgery

• Soft Tissue Thickness (STT)

  Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)

  T0b: baseline after surgery

• Soft Tissue Thickness (STT)

  Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)

  T2: 12 months after implant placement

Secondary Outcomes (72)

• Vertical position of soft tissue (VPS)

  T0a: baseline before surgery

• Vertical position of soft tissue (VPS)

  T0b: baseline after surgery

• Vertical position of soft tissue (VPS)

  T1: 2 weeks after crown delivery, 4 months from surgery

• Vertical position of soft tissue (VPS)

  T2: 12 months after surgery

• Vertical position of soft tissue (VPS)

  T3: 24 months after surgery

Study Arms (2)

Control group

NO INTERVENTION

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.

Test Group

EXPERIMENTAL

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

Device: Volume-stable collagen matrix Geistlich Fibro-Gide®

Interventions

Volume-stable collagen matrix Geistlich Fibro-Gide® 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.

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

Test Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

U.O. Odontostomatologia e Chirurgia del Cavo Orale

Pisa, Italy, 56126, Italy

Location

Related Publications (10)

• Cairo F, Barbato L, Tonelli P, Batalocco G, Pagavino G, Nieri M. Xenogeneic collagen matrix versus connective tissue graft for buccal soft tissue augmentation at implant site. A randomized, controlled clinical trial. J Clin Periodontol. 2017 Jul;44(7):769-776. doi: 10.1111/jcpe.12750. Epub 2017 Jun 29.

  PMID: 28548210 RESULT

• 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.

  PMID: 31815977 RESULT

• 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.

  PMID: 28107560 RESULT

• Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.

  PMID: 16307569 RESULT

• Jemt T. Regeneration of gingival papillae after single-implant treatment. Int J Periodontics Restorative Dent. 1997 Aug;17(4):326-33.

  PMID: 9497723 RESULT

• De Rouck T, Eghbali R, Collys K, De Bruyn H, Cosyn J. The gingival biotype revisited: transparency of the periodontal probe through the gingival margin as a method to discriminate thin from thick gingiva. J Clin Periodontol. 2009 May;36(5):428-33. doi: 10.1111/j.1600-051X.2009.01398.x.

  PMID: 19419444 RESULT

• Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.

  PMID: 3507627 RESULT

• Buser D, Weber HP, Lang NP. Tissue integration of non-submerged implants. 1-year results of a prospective study with 100 ITI hollow-cylinder and hollow-screw implants. Clin Oral Implants Res. 1990 Dec;1(1):33-40. doi: 10.1034/j.1600-0501.1990.010105.x.

  PMID: 2099210 RESULT

• 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.

  PMID: 23062125 RESULT

• 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.

  PMID: 21491763 RESULT

Study Officials

• Antonio Barone, DDS

  University of Pisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 18, 2021
• Study Start: January 10, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)