Evaluation of Post-operative Pain After Stabilization of Free Gingival Graft for Keratinized Tissue Augmentation Around Natural Teeth Using Titanium Tacks Versus Standard Suturing Technique.
12 juin 2026 mis à jour par: Karim Abdelrahim Mohamed Abdelsamad
Clinical Evaluation of Titanium Tacks Used for the Stabilization of Free Gingival Graft in Gingival Augmentation Around Natural Teeth: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to learn whether titanium tacks can be used as an alternative to sutures for stabilization of free gingival grafts (FGG) around natural teeth. It will also evaluate the effect of each stabilization technique on patient comfort and clinical outcomes.
The main questions it aims to answer are:
- Does stabilization of free gingival grafts using titanium tacks reduce post-operative pain compared with conventional suturing?
- Does stabilization of free gingival grafts using titanium tacks affect clinical outcomes such as keratinized tissue width, gingival thickness, graft dimensions, procedure time, plaque accumulation, and interference with daily activities?
Researchers will compare free gingival graft stabilization using titanium tacks with the conventional suturing technique to determine whether titanium tacks provide comparable or improved outcomes.
Participants will:
- Receive a free gingival graft around natural teeth requiring augmentation of keratinized gingival tissue.
- Be assigned to have the graft stabilized either with titanium tacks or with conventional resorbable sutures.
- Attend scheduled follow-up visits for clinical examinations and measurements.
- Report their post-operative pain levels using a Visual Analogue Scale (VAS).
- Complete assessments related to daily life interference during the healing period.
- Undergo evaluation of keratinized tissue width, gingival thickness, graft dimensions, plaque index, and procedure time.
Aperçu de l'étude
Statut
Recrutement
Type d'étude
Interventionnel
Inscription (Estimé)
24
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypte, 11553
- Recrutement
- Faculty of Dentistry and Oral Medicine, Cairo University, Cairo.
-
Contact:
- Karim Abdelsamad
- Numéro de téléphone: 00201006521672
- E-mail: karim.abdelsamad@dentistry.cu.edu.eg
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Patients age 18 years or older.
- Patients with healthy systemic condition.
- Indication for FGG treatment (i.e., difficulty or discomfort during oral hygiene; gingival margin mobility; high muscle attachment and/or frenum pull; shallow vestibule and gingival recession) around natural teeth.
- Keratinized tissue width (KTW) < 2 mm.
- Good oral hygiene.
- Cooperative patients.
Exclusion Criteria:
- Pregnant females.
- Smokers: a contraindication for any plastic periodontal surgery.
- Unmotivated and uncooperative patients with poor oral hygiene.
- Patients with habits that may compromise the longevity and affect the result of the study as parafunctional habits.
- Patients who have undergone periodontal surgery in the same area within 6 months.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Free gingival grafting (FGG) using titanium tacks for stabilization
According to the graft size, 2 to 5 titanium tacks will be used to stabilize and secure the free gingival graft in place to the periosteum at the recipient bed as needed, through anchoring in inter-septal bone and avoiding teeth roots.
The FGG will be stretched by fixing one tack at its distal end, then another tack at its mesial one, followed by the other tacks as required.
|
Stabilization of the free gingival autograft in place using a 5-0 or 6-0 resorbable Prolene suture using a combination of two interrupted sutures, anchoring the grafted tissue to the base of the anatomical papillae, and a horizontal mattress compression suture anchored to the periosteum apical to the bone dehiscence and suspended around the palatal or lingual cingulum of the tooth with the recession defect, allowing for intimate contact ensuring proper perfusion and consequent revascularization of the graft.
|
|
Comparateur actif: Free gingival grafting (FGG) using sutures for stabilization
Stabilization of the free gingival autograft in place using a 5-0 or 6-0 resorbable Prolene suture using a combination of two interrupted sutures, anchoring the grafted tissue to the base of the anatomical papillae, and a horizontal mattress compression suture anchored to the periosteum apical to the bone dehiscence and suspended around the palatal or lingual cingulum of the tooth with the recession defect, allowing for intimate contact ensuring proper perfusion and consequent revascularization of the graft.
|
According to the graft size, 2 to 5 titanium tacks will be used to stabilize and secure the free gingival graft in place to the periosteum at the recipient bed as needed, through anchoring in inter-septal bone and avoiding teeth roots.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative pain
Délai: Daily for the first 7 days post-surgery.
|
Visual Analogue Scale (VAS) with numerical scale from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 1 week postoperatively.
|
Daily for the first 7 days post-surgery.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Keratinized tissue width (KTW)
Délai: Week 12, Week 24
|
Will be measured from the MGJ to the free gingival margin.
The MGJ will be identified using the roll technique.
|
Week 12, Week 24
|
|
Intra-operative/procedure time (PT)
Délai: During the free gingival graft stabilization procedure
|
Will be measured using a stopwatch from the beginning till the end of each procedure.
|
During the free gingival graft stabilization procedure
|
|
Daily life interference
Délai: Daily for the first 7 days post-surgery.
|
It is based on the level of interference of surgical procedure on the patient's normal daily life for the first week after surgery.
|
Daily for the first 7 days post-surgery.
|
|
Gingival thickness
Délai: Week 12, Weeks 24.
|
An endodontic file and a 3 mm diametersilicon disc stop will be used to measure gingival thickness 2mm apical to the gingival border.
The file will be inserted into the soft tissue with mild pressure, perpendicular to the mucosal surface, until a firm surface is felt.
The silicon disc stop will be then pressed against the soft tissue, with the coronal border covering the soft tissue boundary.
|
Week 12, Weeks 24.
|
|
Post-operative Pain [Indirect]
Délai: Daily for the first 7 days post-surgery.
|
It is based on the amount of analgesics patient consumes, only if needed, during the first week after surgery.
This will be measured by the number of pills consumed by the patient after both the pretreatment and 6h post-treatment doses.
|
Daily for the first 7 days post-surgery.
|
|
Plaque Index
Délai: Week 12, Week 24.
|
|
Week 12, Week 24.
|
|
Graft dimensions
Délai: Week 12, Week 24.
|
Will be measured from standardized images using "Image J Software" for standardization of measurements and readings.
|
Week 12, Week 24.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
17 mars 2025
Achèvement primaire (Estimé)
1 février 2027
Achèvement de l'étude (Estimé)
1 juillet 2027
Dates d'inscription aux études
Première soumission
12 juin 2026
Première soumission répondant aux critères de contrôle qualité
12 juin 2026
Première publication (Réel)
17 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 juin 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 28/1/2025
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .