The Use of a Porcine Collagen Matrix for the Prevention of Buccal Bone Wall Resorption During Implant Placement in the Aesthetic Zone.

NCT06622759 | Recruiting Phase 2 DMC

• 1 other identifier: 20/29-06-2023
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: To provide a comparative assessment of the clinical and radiographic effect of porcine collagen matrix when placed buccally at the time of single implant placement in the aesthetic zone vs autogenous connective tissue graft in terms of buccal bone resorption and soft tissue augmentation 6 months post operative. Histological assessment and patient reported outcomes were reported

Conditions

Soft Tissue Augmentation

Keywords

Implants; Esthetic zone; Soft tissue augmentation; Collagen matrix; Soft tissue grafts; Connetive Tissue Graft; Porcine collagen matrix

Outcome Measures

Primary Outcomes (2)

• Soft Tissue Thickness

  Thickness of soft tissue buccally

  6 months

• Buccal Bone Thickness

  Thickness of marginal bone buccally

  6 months

Secondary Outcomes (1)

• Keratinized tissues

  6 months

Other Outcomes (3)

• Full Mouth Bleeding Score

  6 months

• Full mouth plaque score

  6 months

• PROMs (Patient Relative Outcome Measures)

  14 days (after surgical treatment)

Study Arms (3)

No Graft

OTHER

In the control group, the implant will be placed without any kind of soft tissue graft. Also, it will be placed at the level of the bone and the flaps will be sutured with 5/0 absorbable sutures.

Procedure: Control group

CTG

EXPERIMENTAL

In the first experimental group, prosthetically guided implant placement will be performed as well as an increase of the soft tissue volume with an autologous Connective Tissue Graft (CTG). The implant will be placed up to the level of the bone. The autologous graft will be harvested either from the palate as a free gingival graft or as a subepithelial graft, or from the maxillary cusps. The graft will be immobilized in the buccal flap with two simple interrupted sutures and 5/0 absorbable sutures covering the buccal and coronal surfaces of the alveoral bone. Finally, the flap will be displaced coronally so that we have closure in the first place.

Procedure: CTG

Collagen Matrix

EXPERIMENTAL

In the second experimental group, prosthetically guided implant placement and simultaneous soft tissue volume augmentation with porcine Collagen Matrix (CM) - Geistlich FibroGide - will be performed. Initially, full-thickness flap will be raised mainly buccally but also palatally. The implant will then be placed at the level of the bone. The flap will buccally become partial thickness and full thickness again so that we can move it coronally to cover and perfuse the graft. The collagenous graft will be shaped to fit the surgical site, be covered by the periosteum, and will completely cover the buccal bone. Also, it should expand coronal to the alveoral crest. Two horizontal matress sutures (P.G.A 5/0 absorbable) will immobilize the graft. Finally, the buccal flap will be displaced coronally, so that we have convergence in the first place.

Procedure: Collagen Matrix

Interventions

CTG PROCEDURE

Connective Tissue Graft has been widely used around implants to increase either the thickness of the soft tissues or the width of keratinized tissues. It is considered the gold standard for soft tissue grafting. The main drawbacks are the donor morbidity and the limit amount of intraoral donor sites. In this study it will be used in the test 1 group in order to compare its clinical results with the other groups.

CTG

Collagen Matrix PROCEDURE

Collagen matrix has been used in several studies in order to evaluate its clinical properties over the last years. In this study, the graft will be placed buccally at the time of implant placement in the aesthetic zone in order to assess its clinical and radiographic properties in terms of buccal bone resorption and soft tissue augmentation. Histological assessment and Patient Reported outcomes will also be evaluated.

Collagen Matrix

Control group PROCEDURE

In the control group, the implant will be placed without any kind of soft tissue graft in order to compare this treatment modality that many clinicians apply at the clinical practice.

No Graft

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Generally healthy adult patients.
• years or older.
• Need for replacement of single implant in the upper aesthetic zone (second premolar to second premolar)
• Ridge width (bucco-lingual) no greater than 6 mm at its narrowest point.
• Minimum 2mm of attached gingiva.
• Ability to comply with the study related procedures such as exercising good oral hygiene and attending all follow-up examinations.
• Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form

You may not qualify if:

• Poor oral hygiene (FMPS \< 20%, FMBS \< 15%) and poor motivation
• Heavy smokers (\>10 cigarettes per day)
• Need for bone augmentation
• Untreated periodontitis
• General contraindications for dental and/or surgical treatment
• History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years
• Women of child bearing age, not using a standard accepted method for contraception
• Pregnancy or breast feeding
• Previous and concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs
• Disease affecting connective tissue metabolism (e.g. collagenases)
• Allergy to collagen

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Department of Preventive Dentistry, Periodontology &amp; Implant Biology, School of Dentistry, Aristotle University

Thessaloniki, Thessaloniki, 54124, Greece

RECRUITING

Related Publications (11)

• Linkevicius T, Apse P, Grybauskas S, Puisys A. Reaction of crestal bone around implants depending on mucosal tissue thickness. A 1-year prospective clinical study. Stomatologija. 2009;11(3):83-91.

  PMID: 19996674 BACKGROUND

• Linkevicius T, Apse P, Grybauskas S, Puisys A. The influence of soft tissue thickness on crestal bone changes around implants: a 1-year prospective controlled clinical trial. Int J Oral Maxillofac Implants. 2009 Jul-Aug;24(4):712-9.

  PMID: 19885413 BACKGROUND

• Puisys A, Linkevicius T. The influence of mucosal tissue thickening on crestal bone stability around bone-level implants. A prospective controlled clinical trial. Clin Oral Implants Res. 2015 Feb;26(2):123-9. doi: 10.1111/clr.12301. Epub 2013 Dec 9.

  PMID: 24313250 BACKGROUND

• Puisys A, Deikuviene J, Vindasiute-Narbute E, Razukevicus D, Zvirblis T, Linkevicius T. Connective tissue graft vs porcine collagen matrix after immediate implant placement in esthetic area: A randomized clinical trial. Clin Implant Dent Relat Res. 2022 Apr;24(2):141-150. doi: 10.1111/cid.13058. Epub 2022 Mar 24.

  PMID: 35324053 BACKGROUND

• Thoma DS, Zeltner M, Hilbe M, Hammerle CH, Husler J, Jung RE. Randomized controlled clinical study evaluating effectiveness and safety of a volume-stable collagen matrix compared to autogenous connective tissue grafts for soft tissue augmentation at implant sites. J Clin Periodontol. 2016 Oct;43(10):874-85. doi: 10.1111/jcpe.12588. Epub 2016 Aug 12.

  PMID: 27310522 BACKGROUND

• Thoma DS, Gasser TJW, Jung RE, Hammerle CHF. Randomized controlled clinical trial comparing implant sites augmented with a volume-stable collagen matrix or an autogenous connective tissue graft: 3-year data after insertion of reconstructions. J Clin Periodontol. 2020 May;47(5):630-639. doi: 10.1111/jcpe.13271.

  PMID: 32096246 BACKGROUND

• Giannobile WV, Jung RE, Schwarz F; Groups of the 2nd Osteology Foundation Consensus Meeting. Evidence-based knowledge on the aesthetics and maintenance of peri-implant soft tissues: Osteology Foundation Consensus Report Part 1-Effects of soft tissue augmentation procedures on the maintenance of peri-implant soft tissue health. Clin Oral Implants Res. 2018 Mar;29 Suppl 15:7-10. doi: 10.1111/clr.13110.

  PMID: 29498127 BACKGROUND

• Atieh MA, Alsabeeha NHM. Soft tissue changes after connective tissue grafts around immediately placed and restored dental implants in the esthetic zone: A systematic review and meta-analysis. J Esthet Restor Dent. 2020 Apr;32(3):280-290. doi: 10.1111/jerd.12538. Epub 2019 Nov 4.

  PMID: 32311199 BACKGROUND

• Thoma DS, Naenni N, Figuero E, Hammerle CHF, Schwarz F, Jung RE, Sanz-Sanchez I. Effects of soft tissue augmentation procedures on peri-implant health or disease: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Mar;29 Suppl 15:32-49. doi: 10.1111/clr.13114.

  PMID: 29498129 BACKGROUND

• Puzio M, Blaszczyszyn A, Hadzik J, Dominiak M. Ultrasound assessment of soft tissue augmentation around implants in the aesthetic zone using a connective tissue graft and xenogeneic collagen matrix - 1-year randomised follow-up. Ann Anat. 2018 May;217:129-141. doi: 10.1016/j.aanat.2017.11.003. Epub 2017 Dec 15.

  PMID: 29248711 BACKGROUND

• Valles C, Vilarrasa J, Barallat L, Pascual A, Nart J. Efficacy of soft tissue augmentation procedures on tissue thickening around dental implants: A systematic review and meta-analysis. Clin Oral Implants Res. 2022 Jun;33 Suppl 23:72-99. doi: 10.1111/clr.13920.

  PMID: 35763023 BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ioannis Vouros, DDS, Ph.D

  Aristotle Univerity of Thessaloniki

  STUDY CHAIR

Central Study Contacts

Ioannis Vouros, DDS, Ph.D

CONTACT

+302310999597; iovouros@dent.auth.gr

Louiza Papantonatou, DDS

CONTACT

+306984301130; lpapantonatou@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Chair: Ioannis Vouros, DDS, PhD, Professor of Periodontology

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: October 2, 2024
• Study Start: March 24, 2023
• Primary Completion: August 20, 2025
• Study Completion: August 30, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)