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

Phase 3

Active, not recruiting

• Conditions: Dental Implant Failure Nos
• Interventions: Device: NovoMatrix; Other: Control

• Registration Number: NCT05156294
• Lead Sponsor: Universidad Complutense de Madrid

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.

Study Timeline

• Study First Submitted: 2021-11-11
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-14
• Study Start: 2022-01-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-06-10
• Study Completion: 2024-08-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	NovoMatrix	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	Control	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).

Primary Outcome Measures

Name	Time	Method
Change in marginal alveolar crest	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Duration of surgical intervention.	from the tooth extraction to the end of the surgery	Will be measured using the stopwatch, starting from the tooth extraction and ending with the suturing
Change of keratinized tissue width	1 year	Will be measured from the soft tissue margin to the muco-gingival junction at the mid-buccal aspect.
Change in peri-implant soft tissue thickness	1 year	Expressed in millimeters, measured by linear and volumetric analysis. The STL's representing the tissue contours at baseline, 2 months (M), 6M and 12M, will be superimposed to the DICOM files representing the hard tissue at baseline and 12M.
Change of the peri-implant soft tissue health	1 year	Will be measured in six points at the implant of interest, using a University of North Carolina (UNC-15) periodontal probe.
Interproximal recession	1 year	Will be measured as the distance in mm between the peak of the papilla and the incisal edge.
Wound healing	After a week	Will be assessed using Landry index
Full-mouth plaque and bleeding scores	1 year	as the percentage of total surfaces (four aspects per tooth) that revealed plaque (Full mouth plaque score or FMPS, O'Leary et al., 1972) and bleeding on probing, respectively.; Absence or presence of plaque on each surface in the dentition will be recorded in dichotomous manner, with subsequent calculation of the full-mouth plaque score as percentage of the surfaces with plaque to the total number of surfaces assessed; similarly, full-mouth bleeding score will be calculated, assessing presence of bleeding upon gentle probing with standardized force of 0.25 Newtons (N).
Patient-reported outcome measures for pain and discomfort	14 days	will be reported by assessing post-surgical morbidity and patient-reported experience measures (Tonetti et al., 2018); Patients will be instructed to use a post-operative diary for the first 14 days after the surgery to capture patient-reported experience measures.; The diary will be designed to assess patient recovery in four main areas: post-surgery sequelae, pain and discomfort, oral function and interference with daily activities. Patient perception of pain and discomfort will be rated using a Visual Analogue Scale (VAS) scale. Patients will be asked to report the number of tablets and days taken as painkillers or anti-inflammatory drugs.
Patient Global Assessment	1 year	Apart from that, patient perception of the difficulty of surgical intervention, patient perception of pain during the procedure and patient preference for alternate therapy will be recorded at the end of the surgery, using the VAS scale.

Trial Locations

Locations (1)

Universidad Complutense de Madrid; 🇪🇸 Madrid, Mad, Spain