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ACTIVE NOT RECRUITING
NCT05156294
PHASE3

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

Sponsor: Universidad Complutense de Madrid

View on ClinicalTrials.gov

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

Official title: Effect of Soft Tissue Augmentation With an Acellular Dermal Matrix in Marginal Bone Levels Around Implants. A Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-01-10

Completion Date

2024-08-10

Last Updated

2024-05-08

Healthy Volunteers

Yes

Interventions

DEVICE

NovoMatrix

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).

OTHER

Control

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).

Locations (1)

Universidad Complutense de Madrid

Madrid, Mad, Spain