- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07574606
Assessment of Soft Tissue Thickness Over Zygomatic Implants in Atrophied Maxilla Covered With Buccal Fat Pad vs. Palatal Pedicle Flap
Background and Rationale The rehabilitation of the severely atrophied maxilla utilizing zygomatic implants is a highly predictable and effective treatment modality. However, managing the peri-implant soft tissue in these complex cases remains a significant clinical challenge. Because zygomatic implants frequently emerge through thin, non-keratinized, and mobile alveolar mucosa rather than thick, attached gingiva, the peri-implant environment is highly susceptible to complications. Inadequate soft tissue thickness can lead to mucosal recession, exposure of the implant collar, plaque accumulation, and ultimately peri-implantitis, which threatens the long-term success of the prosthesis.
To mitigate these risks and achieve an optimal permucosal seal, soft tissue augmentation is often required. Vascularized soft tissue grafts are preferred in these compromised anatomical sites due to their robust blood supply and enhanced healing capacity. The Buccal Fat Pad (BFP) flap is a well-documented and frequently utilized technique for this purpose; however, its volume can be unpredictable, and it may be unavailable due to prior surgeries or anatomical deficiencies. Therefore, evaluating robust alternatives, such as the Palatal Pedicle Flap (PPF)-which utilizes the thick, keratinized palatal mucosa-is critical for optimizing surgical outcomes.
Study Design and Methodology This study is structured as a prospective, randomized controlled clinical trial utilizing a split-mouth design. The split-mouth approach is strategically chosen to eliminate inter-subject biological and immunological variability, allowing each patient to effectively serve as their own control. Patients presenting with a severely resorbed maxilla requiring bilateral zygomatic implant placement will be enrolled.
Following successful implant placement, the right and left maxillary quadrants will be randomized. One side will be assigned to receive soft tissue augmentation using the standard Buccal Fat Pad (BFP) flap, while the contralateral side will be assigned to receive the Palatal Pedicle Flap (PPF).
Surgical Intervention Overview All surgical procedures will be performed under appropriate anesthesia following standard sterile protocols.
For the BFP side: The buccal fat pad will be accessed via a vestibular mucosal incision, carefully bluntly dissected, mobilized, and advanced over the zygomatic implant collar without tension.
For the PPF side: A palatal pedicle flap will be meticulously outlined, elevated with its vascular supply intact, rotated, and adapted around the contralateral implant collar.
Both flaps will be secured using appropriate resorbable sutures to ensure tension-free primary closure and optimal tissue adaptation around the implant abutment interface. Post-operative care will adhere to standard institutional guidelines, including the prescription of appropriate analgesics, antibiotics, and antimicrobial mouth rinses.
Clinical Significance By systematically comparing the healing trajectories, tissue stability, and functional outcomes of the BFP and PPF techniques over a 6-month period, this trial aims to provide definitive, evidence-based guidance for soft tissue management in zygomatic implantology. Furthermore, it seeks to validate the PPF as a reliable and predictable reconstructive alternative in clinical scenarios where the buccal fat pad is deemed insufficient or inaccessible.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: waleed fathy associate professor of oral and maxillofacial surgery at FUE, associate professor of oral an
- Telefonnummer: 002 +20 10 06614712
- E-post: waleed.fathy@fue.edu.eg
Studera Kontakt Backup
- Namn: aya magdy lecturer of oral and maxillofacial surgery at FUE, LECTURER
- Telefonnummer: 002 00201000252400
- E-post: Aya.magdy@fue.edu.eg
Studieorter
-
-
New Cairo
-
Cairo, New Cairo, Egypten, 11835
- Rekrytering
- Future University in Egypt
-
Kontakt:
- lobna abdelaziz head of department of oral and maxillofacial surgery at FUE, professor
- Telefonnummer: 00201099925769
- E-post: laziz@fue.edu.eg
-
Huvudutredare:
- mohamed abdelhamid maarouf eid, bachelor
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
Patients ≥18 years with severely atrophic maxilla.
- Acquired maxillary defects resulting from trauma, pathology, or previous surgical resection.
- Indicated for zygomatic implant-supported fixed prosthesis.
- Sufficient mouth opening for zygomatic implants placement.
- Patients willing to sign informed consent and attend follow-ups.
Exclusion Criteria:
- Uncontrolled systemic disease affecting healing (e.g., uncontrolled diabetes, etc).
- Heavy smokers
- Previous radiotherapy or bisphosphonate therapy.
- Active sinus or nasal infection.
- Severe parafunctional habits (e.g., bruxism).
- Pregnant or lactating women.
- Patients with psychiatric disorders affecting compliance.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Palatal pedicle flap coverage over zygomatic implant
a palatal pedicle is scored from the palatal mucosa with the greater palatine artery and is rotated to cover the zygomatic implant at the area of the zygomatic implant collar/zaga critical zone.
From the palatal side
|
a palatal pedicle is scored from the palatal mucosa with the greater palatine artery and is rotated to cover the zygomatic implant at the area of the zygomatic implant collar/zaga critical zone.
From the palatal side
|
|
Aktiv komparator: Buccal fat pad coverage over zygomatic implant from the buccal side
|
covering the exposed part of the zygomatic implant using buccal fat pad from the buccal side.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Soft tissue thickness over the implant collar measured using a periodontal probe at 3 points on the buccal, surface mesial and distal to the implant platform.
Tidsram: 6 months
|
6 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: ahmed abozekry, associate professor, oral and maxillofacial surgery at FUE
- Huvudutredare: omar magdy el awady, bachelor
- Studiestol: Ramy Ragab El beialy, Professor, Cairo university in egypt oral and maxillofacial department
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FUE.REC(87)/11-2025
Plan för individuella deltagardata (IPD)
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