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NCT Number: NCT07626866

Peri-Implant Soft Tissue Augmentation Using a Free Connective Tissue Graft With an Epithelial Collar

A prospective randomized interventional clinical trial (RCT) with a parallel-group design is planned. The study sample will include 32 patients randomly allocated into two groups according to the surgical intervention performed. In the first group, a free connective tissue graft with an epithelial collar will be used. In the second group, a free connective tissue graft without an epithelial collar will be used. In the postoperative period, assessment of changes in the width of keratinized mucosa, soft tissue thickness, pain severity, postoperative swelling, and patient quality of life will be performed.

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Key information

Conditions

Soft Tissue Atrophy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, Russia

About this study

The aim of this study is to perform a comparative analysis of the effectiveness of free connective tissue grafts with and without an epithelial collar for peri-implant soft tissue augmentation. Examination and treatment of patients will be carried out at the Department of Oral Surgery of the E.V. Borovsky Institute of Dentistry, Sechenov University.

The study population will include patients with bounded or distal edentulous defects of the upper or lower jaw combined with soft tissue thickness deficiency around dental implants (<2 mm), requiring peri-implant soft tissue augmentation using a free connective tissue graft.

All patients will be randomly allocated into two groups according to the surgical intervention method. In the first group (n=16), a free connective tissue graft without an epithelial collar will be used, while in the second group (n=16), a free connective tissue graft with an epithelial collar will be used. The groups will be comparable in terms of age and sex characteristics.

Patient randomization will be performed intraoperatively as follows: after dental implant placement and preparation of the recipient site, an envelope containing the randomly assigned treatment method will be opened. Patients in both groups will undergo dental implant placement according to the standard surgical protocol combined with peri-implant soft tissue augmentation.

A mucosal incision will be performed followed by elevation of a mucoperiosteal flap, preparation of the implant bed, and placement of the dental implant. Subsequently, the recipient site will be prepared and a free connective tissue graft harvested from the maxillary tuberosity or palatal area. Depending on the allocated group, a graft with or without an epithelial collar will be used. The graft will be fixed to the mucoperiosteal flap, followed by tension-free wound closure, while the donor site will be closed primarily.

In the postoperative period, standard antibacterial and anti-inflammatory therapy combined with topical antiseptic agents will be prescribed.

Who can participate

Healthy volunteers accepted: Yes

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

  • Written informed consent for participation in the study;
  • Age between 18 and 45 years;
  • Bounded edentulous defects of the upper or lower jaw involving 1-2 teeth combined with soft tissue thickness deficiency around dental implants (<2 mm);
  • Teeth without periodontal pathology, with probing depth not exceeding 3 mm throughout the gingival sulcus;
  • Satisfactory level of oral hygiene;
  • Absence of systemic diseases in the stage of exacerbation or decompensation.

Non-inclusion criteria:

  • Patients who previously underwent connective tissue graft harvesting from the same donor site;
  • Patients with impacted third molars in the donor site area;
  • Presence of concomitant diseases in the stage of exacerbation or decompensation;
  • Patients with malignant neoplasms, as well as patients who underwent radiation therapy or chemotherapy within the previous 5 years;
  • Patients with a smoking history of more than 10 years.

Exclusion criteria

  • Patient refusal to continue participation in the study;
  • Pregnant or breastfeeding women;
  • Patients with coagulation disorders (hemophilia, von Willebrand disease, or anticoagulant therapy);
  • Patients with diseases affecting soft tissue healing processes (insulin-dependent diabetes mellitus).

Treatment and study plan

Free connective tissue graft without an epithelial collar

Procedure
  • Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation, preparation of the implant bed and placement of the dental implant according to the standard protocol.
  • Formation of the recipient site in the vestibular area.
  • Harvesting of free connective tissue graft from the maxilla tuberosity area or palate and its adaptation to the recipient site.
  • Fixation of the graft to the vestibular mucosal-periosteal flap and tight suturing of the wound in the recipient area.
  • Suturing of the wound in the donor site.

Free connective tissue graft with epithelial collar

Procedure
  • Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation, preparation of the implant bed and placement of the dental implant according to the standard protocol.
  • Formation of the recipient site in the vestibular area.
  • Harvesting of free connective tissue graft with epithelial strip from the maxilla tuberosity area or palate and its adaptation to the recipient site.
  • Fixation of the graft to the vestibular mucosal-periosteal flap and tight suturing of the wound in the recipient area.
  • Suturing of the wound in the donor site.

Primary outcomes

  1. Change in the Width of Keratinized Mucosa

    Time frame: Day 90 compared to the 0th day (initial value)

    Measurements will be performed using optical impressions obtained with the Primescan intraoral scanner (Dentsply/Sirona) or conventional impressions followed by digital scanning before surgery and on postoperative day 90. Subsequently, STL files will be superimposed using GOM Inspect software, and contour changes will be assessed at three equidistant points.

Secondary outcomes

  1. Change in the Width of Keratinized Mucosa

    Time frame: Day 180 compared to the 0th day (initial value)

    Measurements will be performed using optical impressions obtained with the Primescan intraoral scanner (Dentsply/Sirona) or conventional impressions followed by laboratory scanning before surgery and on postoperative day 180. Subsequently, STL files will be superimposed using GOM Inspect software, and contour changes will be assessed at three equidistant points.

  2. Assessment of Scar Formation According to the Modified Scar Index (MSI)

    Time frame: Day 90 compared to the 0th day (initial value)

    Assessment of postoperative soft tissue scar quality around dental implants is performed using the Modified Scar Index (MSI) according to Mombelli et al., based on the evaluation of five parameters: scar color, scar contour, soft tissue deformity, scar tissue texture, and wound margin separation. Each parameter is assessed using a 3-point scale, where: 0 = optimal tissue condition; 1 = moderate scar changes; 2 = pronounced scar changes. The total MSI score ranges from 0 to 10, with lower scores indicating better clinical outcomes and minimal scar formation. Clinical assessment is performed visually and by palpation, with additional evaluation using clinical photographs when necessary.

  3. Assessment of Scar Formation According to the Modified Scar Index (MSI)

    Time frame: Day 180 compared to the 0th day (initial value)

    Assessment of postoperative soft tissue scar quality around dental implants is performed using the Modified Scar Index (MSI) according to Mombelli et al., based on the evaluation of five parameters: scar color, scar contour, soft tissue deformity, scar tissue texture, and wound margin separation. Each parameter is assessed using a 3-point scale, where: 0 = optimal tissue condition; 1 = moderate scar changes; 2 = pronounced scar changes. The total MSI score ranges from 0 to 10, with lower scores indicating better clinical outcomes and minimal scar formation. Clinical assessment is performed visually and by palpation, with additional evaluation using clinical photographs when necessary.

  4. Assessment of Pain Severity

    Time frame: 4 hours compared to the 0th day (initial value)

    Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.

  5. Assessment of Pain Severity

    Time frame: Day 1 compared to the 0th day (initial value)

    Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.

  6. Assessment of Pain Severity

    Time frame: Day 3 compared to the 0th day (initial value)

    Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.

  7. Assessment of Pain Severity

    Time frame: Day 5 compared to the 0th day (initial value)

    Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.

  8. Assessment of Pain Severity

    Time frame: Day 7 compared to the 0th day (initial value)

    Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.

  9. Assessment of Postoperative Swelling Severity

    Time frame: Day 1 compared to the 0th day (initial value)

    Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.

  10. Assessment of Postoperative Swelling Severity

    Time frame: Day 3 compared to the 0th day (initial value)

    Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.

  11. Assessment of Postoperative Swelling Severity

    Time frame: Day 5 compared to the 0th day (initial value)

    Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.

  12. Assessment of Postoperative Swelling Severity

    Time frame: Day 7 compared to the 0th day (initial value)

    Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.

  13. Assessment of Bleeding

    Time frame: Day 1 compared to the 0th day (initial value)

    Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.

  14. Assessment of Bleeding

    Time frame: Day 3 compared to the 0th day (initial value)

    Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.

  15. Assessment of Bleeding

    Time frame: Day 5 compared to the 0th day (initial value)

    Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.

  16. Assessment of Bleeding

    Time frame: Day 7 compared to the 0th day (initial value)

    Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.

  17. Assessment of Analgesic Intake

    Time frame: Day 1 compared to the 0th day (initial value)

    Assessment of the number of Nimesulide 100 mg tablets taken per day.

  18. Assessment of Analgesic Intake

    Time frame: Day 3 compared to the 0th day (initial value)

    Assessment of the number of Nimesulide 100 mg tablets taken per day.

  19. Assessment of Analgesic Intake

    Time frame: Day 5 compared to the 0th day (initial value)

    Assessment of the number of Nimesulide 100 mg tablets taken per day.

  20. Assessment of Analgesic Intake

    Time frame: Day 7 compared to the 0th day (initial value)

    Assessment of the number of Nimesulide 100 mg tablets taken per day.

  21. Quality of Life Assessment According to OHIP-14

    Time frame: Day 0 (initial value)

    Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions. The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.

  22. Quality of Life Assessment According to OHIP-14

    Time frame: Day 7 compared to the 0th day (initial value)

    Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions. The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.

  23. Quality of Life Assessment According to OHIP-14

    Time frame: Day 90-93 compared to the 0th day (initial value)

    Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions. The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.

  24. Quality of Life Assessment According to OHIP-14

    Time frame: Day 180-186 compared to the 0th day (initial value)

    Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions. The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study title

Application of a Free Connective Tissue Graft With an Epithelial Collar for Peri-Implant Soft Tissue Augmentation in Patients With Soft Tissue Deficiency Around Dental Implants

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

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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