Trials / Completed
CompletedNCT03358667
Increase of Peri-implant Soft Tissues With Screw or Membrane
Comparison Between Dermal Matrix Membrane and Tent-screw Technique for Vertical Increase of Peri-implant Soft Tissues
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 84 (actual)
- Sponsor
- International Piezosurgery Academy · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- —
Summary
The objective of this observational study is to evaluate the growth of peri-implant soft tissues using an heterologous dermal membrane graft (group A) or a 2 mm healing screw used as a vertical support of the limbs (group B) positioned at the moment of surgical insertion of the implant.
Detailed description
The presence of soft tissue over the implants plays an important role both in bone preservation and in enhancing aesthetic conditions. The importance of good quality and amount of soft tissues was indicated by colleagues in 1994: the soft tissue enhancement technique involved inserting, at the site of the implant, a connective tissue graft taken from the palate of the patient itself. The technique was intended to allow a better aesthetic result in the treated area and to prevent metal exposure in case of reabsorption of the vestibular bone. In a systematic review of literature, some authors in 2014 have shown that a soft tissue graft applied to the implant placement area will provide a better aesthetic result. Colleagues in 2010 tested the increase in thickness of peri-implant tissues in a randomized and controlled split-mouth study: at the time of implant placement, a site received a connective plug and one received no graft. The average thickness increase in the grafted sites was 1.3 mm and allowed for aesthetic improvement. In recent years, some human or animal origin materials have been introduced to replace the connective tissue which, being taken by the patient, often binds to a second surgical area with increased morbidity, postoperative discomfort and longer duration of intervention same. The use of deproteinized human dermis was first introduced in plastic surgery in 1995 and ophthalmic in 1999 in the second half of the 90s and then in oral surgery. Recently colleagues used the deproteinized dermis of human origin, placed at the same time as the implants, to evaluate whether the thickening of peri-implant tissues reduced marginal bone resorption after prosthetic loading. Their study showed that areas receiving an insertion had a reduced marginal bone resorption compared to areas with thin soft tissues, without quantifying the increase in soft tissues. In another prospective study, Lorenzo and colleagues in 2011 compared the connective tissue taken from the palate to a dermal matrix of porcine origin to obtain an increase in keratinized tissue bandage: the two techniques yielded similar results. Even in this case, however, the vertical thickness increase of soft tissues was not evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | augmentation peri-implant soft tissue | the implant was cover with a 2 mm cover screw for a tent effect or with a dermal membrane after implant insertion |
Timeline
- Start date
- 2017-11-01
- Primary completion
- 2019-10-31
- Completion
- 2021-03-25
- First posted
- 2017-11-30
- Last updated
- 2021-03-26
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03358667. Inclusion in this directory is not an endorsement.