Effectiveness of Xenogenic Collagen Matrix in Modification of Mucosal Phenotype Around Dental Implants
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Al Mansurah, Egypte
- faculty of dentistry Mansoura university, Mansoura, 35516
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Patient between 25-50 years old.
- Remaining bone height of more than 8 mm, remaining bone width of 6 mm
- Inadequate keratinized soft tissue <2 mm (13).
- Favorable pattern of occlusion.
- Good oral hygiene.
- Patient ability to comply with the required recall visits.
Exclusion Criteria:
- Insufficient bone width (less than 6 mm) mesiodistal or buccolingually.
- Patients having any uncontrolled systemic disease which could affect bone healing.
- Patients treated with radiotherapy to the head and neck area within the past 12 months.
- Heavy Smokers (more than 20 cigarette per day) according to WHO.
- Inability or unwillingness to return for follow-up visits.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: dental implant with application of free gingival graft
Group I: will include 10 patients in which participants will receive dental implant with application of free gingival graft which will be taken from the hard palate to increase the width of keratinize gingiva
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Group I: All patients will be operated under local anaesthesia;. .. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. A gingival graft will be taken from the hard palate. The graft will be 1 to 2 mm in thickness and its size will be determined depending on recipient size and free from adipose tissue. The graft will be trimmed to adapt to the shape and size of the recipient site then suturing the graft to the recipient sites by using 4-0 vicryl suture. Group II: All patients will be operated under the same local anaesthetic as in group I. Crestal incision will be performed and full thickness mucoperiosteal flap will be reflected just to access the site. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. Porcine collagen matrix will be placed in the recipient site and sutured by using 4-0 vicryl suture. |
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Expérimental: dental implants with application of porcine collagen matrix
Group II: will include 10 patients in which participants will receive dental implants with application of porcine collagen matrix to increase the width of keratinize gingiva.
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Group I: All patients will be operated under local anaesthesia;. .. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. A gingival graft will be taken from the hard palate. The graft will be 1 to 2 mm in thickness and its size will be determined depending on recipient size and free from adipose tissue. The graft will be trimmed to adapt to the shape and size of the recipient site then suturing the graft to the recipient sites by using 4-0 vicryl suture. Group II: All patients will be operated under the same local anaesthetic as in group I. Crestal incision will be performed and full thickness mucoperiosteal flap will be reflected just to access the site. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. Porcine collagen matrix will be placed in the recipient site and sutured by using 4-0 vicryl suture. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Clinical Evaluation:
Délai: 3 months
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Wound Healing Status: Presence or absence of soft tissue dehiscence or wound infection. Unit: Yes/No. Time Frame: Post-operative follow-up visits. |
3 months
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clinical
Délai: 3 months
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Implant Stability: Implant stability measured using Resonance Frequency Analysis (Osstell). Unit: Implant Stability Quotient (ISQ). Time Frame: Immediately post-placement and at 3 months. |
3 months
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Clinical
Délai: 3 months
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Surgical Operation Time: Duration of implant site preparation and graft fixation. Unit: Minutes. Time Frame: During surgery. |
3 months
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clinical
Délai: 3 months
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Post-operative Pain Intensity: Patient-reported pain measured using Visual Analogue Scale (VAS). Unit: VAS score (0-10). Time Frame: Day 1, Day 3, and 1 week post-operatively. |
3 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Clinical periodontal parameters
Délai: 3 months
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Plaque Index (PI): Dental plaque accumulation around implants measured using the Plaque Index. Unit: PI score. Time Frame: 3 months post-operatively. |
3 months
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radiographic
Délai: 6 months
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Description: Measurement of crestal bone level changes in the buccolingual direction around the dental implant using CBCT. Unit of Measure: Millimeters (mm) Time Frame: At 6 months post-implant placement |
6 months
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clinical parameters
Délai: 3 months
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Probing Depth (PD): Peri-implant probing depth to assess peri-implant tissue health. Unit: mm. Time Frame: 3 months post-operatively. |
3 months
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clinical perodontal parameters
Délai: 3 months
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Clinical Attachment Level (CAL): Measurement from cemento-enamel junction to base of peri-implant sulcus/pocket. Unit: mm. Time Frame: 3 months post-operatively. |
3 months
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clinical periodontal parameters
Délai: 3 months
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Keratinized Tissue Width (KTW): Width of keratinized mucosa around implant site. Unit: mm. Time Frame: 3 months post-operatively. |
3 months
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clinical periodontal parameters
Délai: 3 months
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Gingival Thickness (GT): Thickness of peri-implant gingiva.
Unit: mm.
Time Frame: 3 months post-operatively.
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3 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: mohamad sa haichal, bachelor, Faculty of Dentistry Mansoura University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- A0101025 OM
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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