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NCT Number: NCT04766255

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

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.

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Key information

Conditions

Soft Tissue Atrophy Edentulous Alveolar Ridge Mucogingival Deformity on Edentulous Ridge

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location status: Recruiting

Location contact

Andres M Pascual La Rocca, Dentist

CONTACT

[email protected]

Cristina V Valles Vega, Dentist

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients referred to Department of Periodontology (CUO) in need of a single implant and need of soft tissue augmentation such as buccal defects, thin biotype, lack of keratinized tissue and aesthetic compromised situation.

  • 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.
  • Palate must have ≥2mm of thickness at premolar area.
  • Full mouth plaque and bleeding score <20%.

Exclusion criteria

  • 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.
  • Heavy smokers (> 10 cigarettes per day).
  • Local or systemic conditions that would interfere with routine periodontal therapy (non-controlled diabetes mellitus, cancer, HIV, Chronic High dose steroid therapy, bone metabolic diseases, radiation, immunosuppressive disorders, liver function disorder, immunosuppressant disease, autoimmune disease).
  • Allergy to non-steroidal anti-inflammatory drugs.
  • Patients taking medications that cause gingival enlargement.

Treatment and study plan

Soft Tissue graft augmentation

Procedure

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

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.

Primary outcomes

  1. soft tissue volume gain

    Time frame: after 3 months

    Optical scans superposition

Secondary outcomes

  1. soft tissue volume stability

    Time frame: after 15 months

    Optical scans superposition

  2. Plaque index (PI)

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

    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)

  3. Bleeding on probing (BI)

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

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

  4. Probing depth (PD)

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

    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.

  5. Width of keratinized tissue (KT)

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

    in the implant area (implant and both teeth nxt to it). Measured in the medial buccal point of the tooth/implant. Distance from mucogingival junction to the most apical portion of the crest of the marginal gingiva. The mucogingival junction will be identified by the roll technique, wherein the mucosa is rolled until the non-movable portion of the attached keratinized tissue is seen

  6. Phenotype evaluation (PT)

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

    the gingival biotype was categorized as thin or thick based on the transparency of a periodontal probe (CP15 UNC; Hu-Friedy, Chicago, IL, USA) through the soft tissues while probing the buccal sulcus of the contra-lateral tooth (17-19)

  7. Patient reported outcome measures (PROMs)

    Time frame: after the surgery procedures (baseline) and after 7 days (suture removal)

    patient pain/discomfort will be evaluated (a questionnaire will be provided to each patient after all the surgery procedures and it will be recollected the day of suture removal)

  8. Pink Esthetic Score (PES)

    Time frame: After 2 weeks of the definite crown placement (around 16 months)

    will be registered to obtain information related to the papilla, the level of soft-tissue margin, the alveolar process, the color, contour and texture of the same soft tissue

Study contacts

Contact information is provided by the study sponsor or research team.

Andres Pascual La Rocca, DDS

CONTACT

[email protected]

0034627725044

Cristina Valles Vega, DDS

CONTACT

[email protected]

0034627725044

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Official study title

Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants in Terms of Volume Gain and Stability Over Time: A Randomized Clinical Trial.

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Feb 23, 2021
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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