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Completed

NCT Number: NCT06065254

Efficacy of Gingival Grafts During the Implantation Process on the Peri-implant Mucosa

This study aims to compare the changes in the peri-implant mucosa during the application of two soft tissue grafting methods, which are free gingival graft (FGG) and connective tissue graft (CTG) taken from the palatine in terms of the width of the keratinized mucosa and the thickness of the peri-implant soft tissues.

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Key information

Conditions

Dental Implants Transplants

Age range

21 year–83 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, Syria

About this study

The presence of adequate width of the keratinized gingiva may be necessary in some special cases such as the presence of fixed prostheses on the teeth with sublingual margins or peri implants. There is an association between insufficiency of the keratinized tissues peri implants with greater plaque accumulation, signs of inflammation, soft tissue recession, and loss of attachment. The sample will consist of 33 dental implant sites and divide randomly into three groups: Group I (Experiential, n=11): FGG; Group II: (Experiential, n=11): CTG; and Group III: (Control, n=11): No procedure will be done to improve the quality of the peri-implant tissues. The width of the keratinized gingiva will be measured preoperative with a UNC-15 and the thickness of the peri-implant soft tissues will be measured clinically by direct transgingival propping method. These measurements will be repeated after 1 and 3 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients who have lost posterior teeth (premolars or molars).
  • A decrease in the amount of keratinized gingiva (less than 2 mm from the alveolar process to the mucogingival junction).
  • good oral health (plaque index ≤1).

Exclusion criteria

  • heavy smokers (more than 10 cigarettes per day)
  • uncontrolled diabetes or other systemic diseases.

Treatment and study plan

Efficacy of free gingival grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness

Other

Two vertical incisions will be made in the previously elevated flap against the placed implant , where these two incisions will be 10 mm apart from each other, and the free graft to will be placed in this distance (10 x 10 mm). The graft will be obtained from the donor site (the hard palate), and will be thinned to obtain a regular graft with the required thickness. After that, the graft will be moved to its correct place accurately, while avoiding leaving a distance between the graft and the tissue underneath, and the graft will be sutured well to ensure its stability and correct placement.

Efficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness

Other

Vertical incisions will not be made in the previously elevated flap against the placed implant, where there is no need to suture the flap apically of the grafting place because the graft will be covered with it after fixing it in place. The area will be washed with the serum to remove the clot before fixing the graft.The graft will be obtained from the donor site according to the previously mentioned method. Then the epithelium will be removed to leave the connective tissue underneath, and then the graft will be moved to its place (buccally dental implant site) and the flap will be sutured over it.

No types of grafts will be made to improve the quality of the peri-implant mucosa

Other

The simple suturing of the two surgical incisions will be done after the completion of the dental implant process, with no procedure will be made to improve the quality of the peri-implant mucosa.

Primary outcomes

  1. The width of the keratinized gingiva

    Time frame: after 1 month and 3 months

    The width of the keratinized gingiva will be measured using a UNC-15 probe from the middle of the alveolar process at the site studied to the mucogingival junction, which was determined by the rollover technique.

  2. The thickness of the peri-implant soft tissues

    Time frame: after 1 month and 3 months

    The thickness of the peri-implant soft tissues will be measured clinically by the direct transgingival propping method.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Efficacy of Gingival Grafts During the Implantation Process in the Increasing of Peri-implant Keratinized Tissue Width and Soft Tissues Thickness

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 3, 2023
Registry last updated
Oct 3, 2023

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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