Clinical trial NCT05156294: Effect of Soft Tissue Augmentation With an Acellular Dermal Matrix in Marginal Bone Levels Around Implants
Official title: Effect of Soft Tissue Augmentation With an Acellular Dermal Matrix in Marginal Bone Levels Around Implants. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Dental Implant Failure Nos
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: doubled-blind, parallel groups, randomized clinical trial
Primary purpose: TREATMENT

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

Detailed description: The study is designed as a doubled-blind, parallel groups, randomized clinical trial with a 1-year follow-up. The randomization sequence will be created using a computer-generated list by an independent researcher. Allocation concealment will be kept by means of opaque sealed envelopes that will be open by one of the researchers during surgery, and revealed to the operator immediately after implant insertion.

All patients will receive standardized oral hygiene instructions consisting on the use of a manual or power-driven toothbrush and specific interdental brushes. Then, patients will be randomized to one of the following groups:

* Test Group :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)
* Control Group: All the procedures will be the same as in the Test Group, with the only difference that no attempt to thicken the mucosa with the acellular dermal matrix will be performed.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in marginal alveolar crest
timeFrame: 1 year
Secondary outcomes:
measure: Duration of surgical intervention.
timeFrame: from the tooth extraction to the end of the surgery
measure: Wound healing
timeFrame: After a week
measure: Change of keratinized tissue width
timeFrame: 1 year
measure: Change in peri-implant soft tissue thickness
timeFrame: 1 year
measure: Change of the peri-implant soft tissue health
timeFrame: 1 year
measure: Interproximal recession
timeFrame: 1 year
measure: Full-mouth plaque and bleeding scores
timeFrame: 1 year
measure: Patient-reported outcome measures for pain and discomfort
timeFrame: 14 days
measure: Patient Global Assessment
timeFrame: 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
state: Mad
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.