Clinical trial NCT05081284: Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix
Official title: Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Edentulous Alveolar Ridge
Keywords: Soft tissue augmentation
Immediate implant
Collagen matrix
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Soft Tissue Thickness (STT)
timeFrame: T0a: baseline before surgery
measure: Soft Tissue Thickness (STT)
timeFrame: T0b: baseline after surgery
measure: Soft Tissue Thickness (STT)
timeFrame: T2: 12 months after implant placement
Secondary outcomes:
measure: Vertical position of soft tissue (VPS)
timeFrame: T0a: baseline before surgery
measure: Vertical position of soft tissue (VPS)
timeFrame: T0b: baseline after surgery
measure: Vertical position of soft tissue (VPS)
timeFrame: T1: 2 weeks after crown delivery, 4 months from surgery
measure: Vertical position of soft tissue (VPS)
timeFrame: T2: 12 months after surgery
measure: Vertical position of soft tissue (VPS)
timeFrame: T3: 24 months after surgery
measure: Vertical position of soft tissue (VPS)
timeFrame: T4: 36 months after surgery
measure: Assessment of the linear volumetric changes
timeFrame: T0a: baseline before surgery
measure: Assessment of the linear volumetric changes
timeFrame: T1: 2 weeks after crown delivery, 4 months from surgery
measure: Assessment of the linear volumetric changes
timeFrame: T2: 12 months after surgery
measure: Assessment of the linear volumetric changes
timeFrame: T3: 24 months after surgery
measure: Assessment of the linear volumetric changes
timeFrame: T4: 36 months after surgery
measure: Pink Esthetic Score (PES)
timeFrame: T1: 2 weeks after crown delivery, 4 months from surgery
measure: Pink Esthetic Score (PES)
timeFrame: T2: 12 months after surgery
measure: Pink Esthetic Score (PES)
timeFrame: T3: 24 months after surgery
measure: Pink Esthetic Score (PES)
timeFrame: T4: 36 months after surgery
measure: Papillae index (PI)
timeFrame: T0a: baseline before surgery
measure: Papillae index (PI)
timeFrame: T0b: baseline after surgery
measure: Papillae index (PI)
timeFrame: T1: 2 weeks after crown delivery, 4 months from surgery
measure: Papillae index (PI)
timeFrame: T2: 12 months after surgery
measure: Papillae index (PI)
timeFrame: T3: 24 months after surgery
measure: Papillae index (PI)
timeFrame: T4: 36 months after surgery
measure: Width of keratinized tissue (WKT)
timeFrame: T0a: baseline before surgery
measure: Width of keratinized tissue (WKT)
timeFrame: T1: 2 weeks after crown delivery, 4 months from surgery
measure: Width of keratinized tissue (WKT)
timeFrame: T2: 12 months after surgery
measure: Width of keratinized tissue (WKT)
timeFrame: T3: 24 months after surgery
measure: Width of keratinized tissue (WKT)
timeFrame: T4: 36 months after surgery
measure: Peri-implant marginal bone level (MBL)
timeFrame: T0b: baseline after surgery
measure: Peri-implant marginal bone level (MBL)
timeFrame: T1: 2 weeks after crown delivery, 4 months from surgery
measure: Peri-implant marginal bone level (MBL)
timeFrame: T2: 12 months after surgery
measure: Peri-implant marginal bone level (MBL)
timeFrame: T3: 24 months after surgery
measure: Peri-implant marginal bone level (MBL)
timeFrame: T4: 36 months after surgery
measure: Phenotype
timeFrame: T0a: baseline before surgery
measure: Phenotype
timeFrame: T1: 2 weeks after crown delivery, 4 months from surgery
measure: Phenotype
timeFrame: T2: 12 months after surgery
measure: Phenotype
timeFrame: T3: 24 months after surgery
measure: Phenotype
timeFrame: T4: 36 months after surgery
measure: Probing pocket depth (PD)
timeFrame: T0a: baseline before surgery
measure: Probing pocket depth (PD)
timeFrame: T1: 2 weeks after crown delivery, 4 months from surgery
measure: Probing pocket depth (PD)
timeFrame: T2: 12 months after surgery
measure: Probing pocket depth (PD)
timeFrame: T3: 24 months after surgery
measure: Probing pocket depth (PD)
timeFrame: T4: 36 months after surgery
measure: Modified Plaque Index (mPI)
timeFrame: T0a: baseline before surgery
measure: Modified Plaque Index (mPI)
timeFrame: T1: 2 weeks after crown delivery, 4 months from surgery
measure: Modified Plaque Index (mPI)
timeFrame: T2: 12 months after surgery
measure: Modified Plaque Index (mPI)
timeFrame: T3: 24 months after surgery
measure: Modified Plaque Index (mPI)
timeFrame: T4: 36 months after surgery
measure: Gingival bleeding on probing (BoP)
timeFrame: T0a: baseline before surgery
measure: Gingival bleeding on probing (BoP)
timeFrame: T1: 2 weeks after crown delivery, 4 months from surgery
measure: Gingival bleeding on probing (BoP)
timeFrame: T2: 12 months after surgery
measure: Gingival bleeding on probing (BoP)
timeFrame: T3: 24 months after surgery
measure: Gingival bleeding on probing (BoP)
timeFrame: T4: 36 months after surgery
measure: Implant success
timeFrame: T1: 2 weeks after crown delivery, 4 months from surgery
measure: Implant success
timeFrame: T2: 12 months after surgery
measure: Implant success
timeFrame: T3: 24 months after surgery
measure: Implant success
timeFrame: T4: 36 months after surgery
measure: Biological and technical complication
timeFrame: T0a: baseline before surgery
measure: Biological and technical complication
timeFrame: T0b: baseline after surgery
measure: Biological and technical complication
timeFrame: T1: 2 weeks after crown delivery, 4 months from surgery
measure: Biological and technical complication
timeFrame: T2: 12 months after surgery
measure: Biological and technical complication
timeFrame: T3: 24 months after surgery
measure: Biological and technical complication
timeFrame: T4: 36 months after surgery
measure: Surgery time
timeFrame: T0a-b: baseline
measure: Patient satisfaction OHIP-14
timeFrame: T0a: baseline before surgery
measure: Patient satisfaction OHIP-14
timeFrame: T1: 2 weeks after crown delivery, 4 months from surgery
measure: Patient satisfaction OHIP-14
timeFrame: T2: 12 months after surgery
measure: Patient satisfaction OHIP-14
timeFrame: T3: 24 months after surgery
measure: Patient satisfaction OHIP-14
timeFrame: T4: 36 months after surgery
measure: Patient satisfaction VAS
timeFrame: T0a: baseline before surgery
measure: Patient satisfaction VAS
timeFrame: T1: 2 weeks after crown delivery, 4 months from surgery
measure: Patient satisfaction VAS
timeFrame: T2: 12 months after surgery
measure: Patient satisfaction VAS
timeFrame: T3: 24 months after surgery
measure: Patient satisfaction VAS
timeFrame: T4: 36 months after surgery
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: U.O. Odontostomatologia e Chirurgia del Cavo Orale
Study officials:
affiliation: University of Pisa
name: Antonio Barone, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Jemt T. Regeneration of gingival papillae after single-implant treatment. Int J Periodontics Restorative Dent. 1997 Aug;17(4):326-33.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.