Soft Tissue Volume Gain and Stability Comparing Palate and Tuberosity

NCT03090906 | Unknown

• 1 other identifier: PER- ECL-2011-10-NF
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to compare clinical and histologically the soft tissue changes in terms of volume gain and stability around dental implants in cases where a subepithelial connective tissue graft from the palate or from the tuberosity is used randomly

Conditions

Tooth Loss; Recession, Gingival

Keywords

volume gain; soft tissue augmentation; dental implants; histology

Outcome Measures

Primary Outcomes (2)

• Soft tissue volume gain

  Following soft tissue augmentation procedure volume gain is registered using intraoral optical scan. Superposition between three dimensional images from baseline (before augmentation procedure) and 3 months postoperative is done.

  Baseline to 3 months postoperative

• Soft tissue stability

  To evaluate soft tissue stability an intraoral optical scan is performed at 4 and 12 months postoperative. Also a superimposition between 4 months and 12 months optical images is done.

  4 months postoperative to 12 months postoperative

Secondary Outcomes (4)

• Histology

  Baseline

• Clinical periodontal parameters Plaque Index and Bleeding on probing

  Baseline, 3 months, 4 months, 12 months

• Clinical periodontal parameters.Probing depth

  Baseline, 3 months, 4 months, 12 months

• Clinical periodontal parameters. Width of keratinized tissue

  Baseline, 3 months, 4 months, 12 months

Study Arms (2)

Control group: SCTG from palate

EXPERIMENTAL

Soft tissue augmentation palate

Procedure: Soft tissue augmentation palate; Device: Intraoral optical scan

Test group: SCTG from tuberosity

EXPERIMENTAL

Soft tissue augmentation tuberosity

Procedure: Soft tissue augmentation tuberosity; Device: Intraoral optical scan

Interventions

Soft tissue augmentation palate PROCEDURE

Recipient site: Intrasulcular incision at the buccal side of the implant extending in one adjacent tooth for each side and a partial-thickness mucosal flap raised. The connective tissue was secured with suture. Allocation to either treatment was performed according to a randomization table. Donor site A double-bladed scalpel handle 1,5mm was used in both areas to obtain the same thickness. Palate (CG) The double incision was made approximately 2 to 3 mm apical to the gingival margins of premolars. The donor tissue was removed and cross-mattress sutures were used to approximate the wound on the palate. In both groups the epithelial collar removed. Graft required dimensions for both groups:10mm height, 12mm length and 1,5mm thick.

Also known as: subepithelial connective tissue graft

Control group: SCTG from palate

Soft tissue augmentation tuberosity PROCEDURE

Recipient site: Intrasulcular incision at the buccal side of the implant extending in one adjacent tooth for each side and a partial-thickness mucosal flap raised. The connective tissue was secured with suture. Allocation to either treatment was performed according to a randomization table. Donor site A double-bladed scalpel handle 1,5mm was used in both areas to obtain the same thickness. Tuberosity (TG) The double incision was made from the distal of the terminal tooth. A second incision was made perpendicular to the linear incision at a distal point, which joined the two linear incisions. The graft was removed and a crossed horizontal suspension suture was used. Epithelial collar removed. Graft required dimensions for both groups:10mm height, 12mm length and 1,5mm thick.

Also known as: subepithelial connective tissue graft

Test group: SCTG from tuberosity

Intraoral optical scan DEVICE

Intraoral optical scan was performed at both groups at baseline, 3 months, 4 months and 12 months to be able to compare volumetric changes.

Control group: SCTG from palate; Test group: SCTG from tuberosity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be ≥18 years and able to understand the nature of the proposed surgery and to a signed informed consent.
• Implant must be located between 2 fixed reference points i.e. clinical crowns.
• All implants locations with a need of a soft tissue volume augmentation.
• Palate must have ≥2mm of thickness at premolar area.
• Tuberosity \> 12mm in length.
• Full mouth plaque and bleeding score \<20%.

You may not qualify if:

• Previous soft tissue augmentation in the area.
• Heavy Smokers (\> 10 cigarettes per day).
• Local or systemic conditions that would interfere with routine periodontal therapy (non controlled diabetes, liver function disorder, immunosuppressant disease, autoimmune disease).
• Allergy to Non-Steroidal Anti-Inflammatory Drugs.
• Patients taking medications that cause gingival enlargement
• Gingival idiopatic overgrowth

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead
• Osteology Foundation: collaborator

MeSH Terms

Conditions

Tooth Loss; Gingival Recession

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Gingival Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Section of Periodontology

Study Record Dates

• First Submitted: January 29, 2017
• First Posted: March 27, 2017
• Study Start: April 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share