Effectiveness of Xenogenic Collagen Matrix in Modification of Mucosal Phenotype Around Dental Implants
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Al Mansurah, Egypte
- faculty of dentistry Mansoura university, Mansoura, 35516
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Experimenteel: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Clinical Evaluation:
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Clinical periodontal parameters
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: mohamad sa haichal, bachelor, Faculty of Dentistry Mansoura University
Studie record data
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Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- A0101025 OM
Plan Individuele Deelnemersgegevens (IPD)
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