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

29 maggio 2026 aggiornato da: I.M. Sechenov First Moscow State Medical University

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

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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

32

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Russia
      • Moscow, Russia
        • I.M. Sechenov First Moscow State Medical University (Sechenov University)

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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

Non-inclusion criteria:

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

Exclusion Criteria:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: first group
Patients will receive a free connective tissue graft without an epithelial collar
Procedura: Free connective tissue graft without an epithelial collar
  1. 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.
  2. Formation of the recipient site in the vestibular area.
  3. Harvesting of free connective tissue graft from the maxilla tuberosity area or palate and its adaptation to the recipient site.
  4. Fixation of the graft to the vestibular mucosal-periosteal flap and tight suturing of the wound in the recipient area.
  5. Suturing of the wound in the donor site.
Sperimentale: second group
Patients will receive a free connective tissue graft with epithelial collar
Procedura: Free connective tissue graft with epithelial collar
  1. 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.
  2. Formation of the recipient site in the vestibular area.
  3. Harvesting of free connective tissue graft with epithelial strip from the maxilla tuberosity area or palate and its adaptation to the recipient site.
  4. Fixation of the graft to the vestibular mucosal-periosteal flap and tight suturing of the wound in the recipient area.
  5. Suturing of the wound in the donor site.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in the Width of Keratinized Mucosa
Lasso di tempo: 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.
Day 90 compared to the 0th day (initial value)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in the Width of Keratinized Mucosa
Lasso di tempo: 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.
Day 180 compared to the 0th day (initial value)
Assessment of Scar Formation According to the Modified Scar Index (MSI)
Lasso di tempo: 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.
Day 90 compared to the 0th day (initial value)
Assessment of Scar Formation According to the Modified Scar Index (MSI)
Lasso di tempo: 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.
Day 180 compared to the 0th day (initial value)
Assessment of Pain Severity
Lasso di tempo: 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.
4 hours compared to the 0th day (initial value)
Assessment of Pain Severity
Lasso di tempo: 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.
Day 1 compared to the 0th day (initial value)
Assessment of Pain Severity
Lasso di tempo: 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.
Day 3 compared to the 0th day (initial value)
Assessment of Pain Severity
Lasso di tempo: 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.
Day 5 compared to the 0th day (initial value)
Assessment of Pain Severity
Lasso di tempo: 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.
Day 7 compared to the 0th day (initial value)
Assessment of Postoperative Swelling Severity
Lasso di tempo: 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.
Day 1 compared to the 0th day (initial value)
Assessment of Postoperative Swelling Severity
Lasso di tempo: 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.
Day 3 compared to the 0th day (initial value)
Assessment of Postoperative Swelling Severity
Lasso di tempo: 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.
Day 5 compared to the 0th day (initial value)
Assessment of Postoperative Swelling Severity
Lasso di tempo: 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.
Day 7 compared to the 0th day (initial value)
Assessment of Bleeding
Lasso di tempo: 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.
Day 1 compared to the 0th day (initial value)
Assessment of Bleeding
Lasso di tempo: 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.
Day 3 compared to the 0th day (initial value)
Assessment of Bleeding
Lasso di tempo: 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.
Day 5 compared to the 0th day (initial value)
Assessment of Bleeding
Lasso di tempo: 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.
Day 7 compared to the 0th day (initial value)
Assessment of Analgesic Intake
Lasso di tempo: Day 1 compared to the 0th day (initial value)
Assessment of the number of Nimesulide 100 mg tablets taken per day.
Day 1 compared to the 0th day (initial value)
Assessment of Analgesic Intake
Lasso di tempo: Day 3 compared to the 0th day (initial value)
Assessment of the number of Nimesulide 100 mg tablets taken per day.
Day 3 compared to the 0th day (initial value)
Assessment of Analgesic Intake
Lasso di tempo: Day 5 compared to the 0th day (initial value)
Assessment of the number of Nimesulide 100 mg tablets taken per day.
Day 5 compared to the 0th day (initial value)
Assessment of Analgesic Intake
Lasso di tempo: Day 7 compared to the 0th day (initial value)
Assessment of the number of Nimesulide 100 mg tablets taken per day.
Day 7 compared to the 0th day (initial value)
Quality of Life Assessment According to OHIP-14
Lasso di tempo: 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.
Day 0 (initial value)
Quality of Life Assessment According to OHIP-14
Lasso di tempo: 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.
Day 7 compared to the 0th day (initial value)
Quality of Life Assessment According to OHIP-14
Lasso di tempo: 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.
Day 90-93 compared to the 0th day (initial value)
Quality of Life Assessment According to OHIP-14
Lasso di tempo: 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.
Day 180-186 compared to the 0th day (initial value)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

I.M. Sechenov First Moscow State Medical University

Investigatori

  • Investigatore principale: Igor P Ashurko, I.M. Sechenov First Moscow State Medical University (Sechenov University)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 giugno 2024

Completamento primario (Stimato)

20 giugno 2026

Completamento dello studio (Stimato)

20 agosto 2026

Date di iscrizione allo studio

Primo inviato

29 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 maggio 2026

Primo Inserito (Effettivo)

4 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • AI-05

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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