Effect of Soft Tissue Augmentation With an Acellular Dermal Matrix in Marginal Bone Levels Around Implants

NCT05156294 | Active Not Recruiting Phase 3 DMC FDA Device

• 1 other identifier: 21/622-EC_P
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to evaluate the efficacy of an acellular dermal matrix membrane to increase the peri-implant soft tissue thickness and to reduce marginal bone loss during non-submerged implant placement, as compared with the standard protocol for implant placement. The test hypothesis is that placing an acellular dermal matrix membrane simultaneous to implant placement in the posterior mandible, will increase the soft tissue thickness and consequently reduce the marginal bone level changes. The study is designed as a doubled-blind, parallel groups, randomized clinical trial with a 1-year follow-up

Conditions

Dental Implant Failure Nos

Outcome Measures

Primary Outcomes (1)

• Change in marginal alveolar crest

  The primary outcome variable of this trial is the change in the marginal alveolar crest after the surgical intervention, assessed by the radiographic change of interproximal bone levels. It will be assessed with periapical radiographs, immediately after surgery and at 6 months and 12 months after loading, by means of computer image analysis software (Image J, National Institute of Health \[NIH\], Bethesda, Maryland). The calibration of the periapical radiographs will be performed using the distance between two implant threads or the length of the implant.

  1 year

Secondary Outcomes (9)

• Duration of surgical intervention.

  from the tooth extraction to the end of the surgery

• Wound healing

  After a week

• Change of keratinized tissue width

  1 year

• Change in peri-implant soft tissue thickness

  1 year

• Change of the peri-implant soft tissue health

  1 year

Study Arms (2)

Test

EXPERIMENTAL

Mucoperiosteal flaps will be raised and the conventional drilling sequence for implants will be implemented (Camlog Conelog Screw-Line Promote Plus implants). Implants will be placed 1 mm below the bone crest. The diameter of the implant will be in the range of 3.8 and 4.3 mm. Consecutively, 4 to 6 mm height healing abutments and the allogenic membrane (NovoMatrix®, BioHorizon) folded in two on top of the implant (secured with the healing abutment), will be placed. Finally, flaps will be sutured with 6/0 polypropylene monofilament. Patients will be instructed to rinse with 15 ml of 0.12% chlorhexidine (Perio-Aid tratamiento, Dentaid SL, Barcelona, Spain) 60 seconds twice per day until suture removal, that will take place 14 days later. Anti-inflammatory drugs will also be prescribed (Ibuprofen 600 mg every 8 hours upon patient´s needs).

Device: NovoMatrix

Control

OTHER

Mucoperiosteal flaps will be raised and the conventional drilling sequence for implants will be implemented (Camlog Conelog Screw-Line Promote Plus implants). Implants will be placed 1 mm below the bone crest. The diameter of the implant will be in the range of 3.8 and 4.3 mm. Finally, flaps will be sutured with 6/0 polypropylene monofilament. Patients will be instructed to rinse with 15 ml of 0.12% chlorhexidine (Perio-Aid tratamiento, Dentaid SL, Barcelona, Spain) 60 seconds twice per day until suture removal, that will take place 14 days later. Anti-inflammatory drugs will also be prescribed (Ibuprofen 600 mg every 8 hours upon patient´s needs).

Other: Control

Interventions

NovoMatrix DEVICE

Implants of Camlog Conelog Screw-Line Promote Plus will be placed. Implants will be placed 1 mm below the bone crest. The diameter of the implant will be in the range of 3.8 and 4.3 mm. Consecutively, 4 to 6 mm height healing abutments and the allogenic membrane (NovoMatrix®, BioHorizon) folded in two on top of the implant (secured with the healing abutment), will be placed. Finally, flaps will be sutured with 6/0 polypropylene monofilament. Patients will be instructed to rinse with 15 ml of 0.12% chlorhexidine (Perio-Aid tratamiento, Dentaid SL, Barcelona, Spain) 60 seconds twice per day until suture removal, that will take place 14 days later. Anti-inflammatory drugs will also be prescribed (Ibuprofen 600 mg every 8 hours upon patient´s needs).

Test

Control OTHER

Implants of Camlog Conelog Screw-Line Promote Plus will be placed. Implants will be placed 1 mm below the bone crest. The diameter of the implant will be in the range of 3.8 and 4.3 mm. Finally, flaps will be sutured with 6/0 polypropylene monofilament. Patients will be instructed to rinse with 15 ml of 0.12% chlorhexidine (Perio-Aid tratamiento, Dentaid SL, Barcelona, Spain) 60 seconds twice per day until suture removal, that will take place 14 days later. Anti-inflammatory drugs will also be prescribed (Ibuprofen 600 mg every 8 hours upon patient´s needs).

Control

Eligibility Criteria

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

You may qualify if:

• Systemically healthy
• Periodontally healthy or with stable treated periodontitis and good oral hygiene (Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS) ≤ 15%, measured at six sites per tooth)
• Need for one or two implants in the posterior mandible (maximum of three missing teeth).
• Enough bone availability to place an implant with a minimum diameter of 3.8 mm and at least 7 mm length.
• Non-smoker or smokers \< 10 cig/day (self-reported).
• Ability to understand the study procedures and to comply with them to the entire length of the study.

You may not qualify if:

• Subjects with uncontrolled systemic diseases (ASA type III).
• Subjects taking medications with immunosuppressors, bisphosphonates or high doses of corticosteroids; current drug or alcohol use or dependence that could interfere with adherence to study requirements.
• Pregnant or lactating women.
• Allergy to collagen or analgesics/anti-inflammatory non-steroid drugs.
• History of cancer requiring radiotherapy or chemotherapy during the last 5 years.
• Local inflammation (including untreated periodontitis)
• Severe bruxism or clenching habits.
• Any kind of bone augmentation performed on the implant site, with a healing period \<6 months
• Less than 4 mm of keratinized mucosa
• Post-extraction sites with \<12 weeks of healing
• Lack of primary implant stability assessed intrasurgically.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Universidad Complutense de Madrid

Madrid, Mad, 28040, Spain

Location

Related Publications (4)

• Canullo L, Fedele GR, Iannello G, Jepsen S. Platform switching and marginal bone-level alterations: the results of a randomized-controlled trial. Clin Oral Implants Res. 2010 Jan;21(1):115-21. doi: 10.1111/j.1600-0501.2009.01867.x.

  PMID: 20070752 BACKGROUND

• O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.

  PMID: 4500182 BACKGROUND

• Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.

  PMID: 29926952 BACKGROUND

• Linkevicius T, Puisys A, Steigmann M, Vindasiute E, Linkeviciene L. Influence of Vertical Soft Tissue Thickness on Crestal Bone Changes Around Implants with Platform Switching: A Comparative Clinical Study. Clin Implant Dent Relat Res. 2015 Dec;17(6):1228-36. doi: 10.1111/cid.12222. Epub 2014 Mar 28.

  PMID: 24673875 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinical examiners evaluating and recording the outcome measurements will be masked to the treatment allocation and the patients will be asked not to reveal their treatment assignment to the examiners.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: doubled-blind, parallel groups, randomized clinical trial

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 14, 2021
• Study Start: January 10, 2022
• Primary Completion: June 10, 2024
• Study Completion: August 10, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

ES (1)