Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants.

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitat Internacional de Catalunya

About this trial

The purpose of the study is to compare soft tissue volume changes in terms of volume gain and stability around dental implants and PROMS in cases where a sub-epithelial connective tissue graft (SCTG) from the palate, Porcine collagen matrix (CM) or Porcine Acellular dermal matrix (PADM) is used after 3 and 15 months after implant placement.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The patient must be ≥18 years and able to understand the nature of the proposed surgery and must sign an informed consent.

The implant must be located between 2 fixed reference points (i.e. clinical crowns).

Anterior and premolar teeth (from premolar to premolar).

Enough crestal bone width to leave a minimum thickness of 2mm at the buccal bone plate when placing the implant.

Disqualifiers

Pregnant or lactation.

Active periodontal disease.

Previous soft tissue augmentation in the area.

Need of guided bone regeneration (GBR) during or after the placement of the implant.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Soft Tissue graft augmentation

    Procedure/Surgery

    Donor site: SCTG group: The SCTG will be harvested in the palat,In order to extract the same thickness in each grafts a double-bladed knife (separated by 1,5mm) will be used. The donor area will be sutured. Recipient site: SCTG group: the connective tissue graft will be trimmed to the correct dimensions (10mm height, 12mm length and 1,5mm thick) and placed and secured at the recipient site with a resorbable 5-0 suture CM group: The CM graft (Geistlich Fibro-gide) will be trimmed to the indicated dimensions (10mm height, 12mm length) and placed and secured at the recipient site with resorbable 5-0 suture PADM Group: the ADM (NovoMatrix, Biohorizons, Birmingham AL) graft will be trimmed to the indicated dimensions (10mm height, 12mm length) and placed and secured at the recipient site with resorbable 5-0 suture

  • Implant Placement

    Procedure/Surgery

    A crestal incision will be made in the implant reception area, extending from the distal of the most mesial tooth to the mesial of the most distal tooth. A mucoperiosteal flap will be elevated in the most crestal part of the ridge. The receptor bed will be prepared following the established drilling protocol for the placement of a BioHorizons Tapered Pro Implant (Biohorizons, Birmingham AL). The diameter and length of the implant will be previously established during the implant study. Later a healing abutment will be placed.

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Control GroupActive comparator 1 intervention
Group B: SCTG groupExperimental treatment 2 interventions
Group C: CM groupExperimental treatment 2 interventions
Group D: PADM groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

soft tissue volume gain

Optical scans superposition

Time frame
after 3 months

Secondary outcomes

1

soft tissue volume stability

Optical scans superposition

Time frame
after 15 months
2

Plaque index (PI)

Each tooth will be divided in 4 surfaces: buccal, lingual, mesial, distal. After the application of erythrosine, O'Leary plaque index will be registered (O'Leary et al. 1972)

Time frame
at baseline, after 12 weeks and after 15 months.
3

Bleeding on probing (BI)

Each tooth will be divided in 4 surfaces: buccal, lingual, mesial, distal. After a gentle probing if the gingiva bleeds will be positive.

Time frame
at baseline, after 12 weeks and after 15 months.
4

Probing depth (PD)

in the implant area (implant and both tooth next to it). Distance from the gingival margin to the bottom of the gingival sulcus using periodontal probe (UNC 15). Measured in 6 points: mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual.

Time frame
at baseline, after 12 weeks and after 15 months.

Other outcomes

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