Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647199
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Evaluation of Peri-Implant Tissues of Different Implant Assisted Overdentures
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Evaluation of Peri-Implant Tissues of CADCAM Milled PEEK PMMA and Conventional Implant Assisted Overdentures
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The researchers will perform a parallel randomized clinical trial involving completely edentulous healthy patients Each participant will receive four dental implants in the anterior mandible According to the processing technique and denture base material the patients will be classified into three groups Group I involves CADCAM milled poly ether ether ketone PEEK overdentures Group II involves CADCAM milled PMMA overdentures and Group III involves conventional heat-cured poly methyl methacrylate PMMA overdentures All assessments were carried out at delivery 6 moths and one year after overdenture insertion to clinically evaluate the preiimplant tissues
Detailed Description:
The study will be conducted to compare three different mandibular implant- assisted complete overdentures These overdentures were constructed from three different materials and techniques CADCAM-milled poly ether ether ketone CADCAM PEEK MOD CADCAM-milled poly methyl methacrylate CADCAM PMMA MOD and conventional heat-cured poly methyl methacrylate conventional PMMA MOD to clinically evaluate the preiimplant tissues
The participants enrolled in the current study were randomly assigned to one of three groups based on the material and technique of their mandibular overdenture bases All participants were delivered new sets of conventional complete dentures implied bilateral balanced occlusal scheme They were well instructed to wear their dentures regularly for 3 months prior to implant installment ascribed to enhancement of the neuromuscular adaptation For each patient the mandibular denture was duplicated with clear auto- polymerizing acrylic resin to fabricate the mandibular surgical template with gutta percha markers By employing CBCT all patients were scanned conforming to the dual scan protocol The implants were installed virtually parallel to each other and perpendicular to the occlusal plane at the areas of canines and lateral incisors This was carried out using 3D image planning software The surgical stent with four sleeves was constructed by rapid prototyping It was placed over the proposed implant locationsFour dental implants were surgically placed in the anterior region of the mandibleThree months afterward the mandibular impression was registered The primary impression was recorded and poured to gain the primary cast Upon that primary cast a closed custom tray was constructed The positioner attachments were screwed to the implants the processing caps and metal housings were secured over them The custom tray was border molded By using silicon impression material the definitive impression was made at the abutment level The processing caps and the metal housings were removed from the impression which was being poured by extra hard scannable dental stone to obtain the master cast Maxillomandibular relations were registered This was accomplished with mandibular conventional record blocks opposed by the existing maxillary complete denture Semi anatomical acrylic teeth were arranged employing bilateral balanced occlusion The waxed overdentures were tried in the patients mouth According to the mandibular denture base material and processing technique of the prostheses the subjects were divided into three groups The first group I included 10 participants whose mandibular overdentures were fabricated by milling pre-polymerized poly ether ether ketone PEEK discs CADCAM PEEK MODs the second groupII included 10 participants whose mandibular overdentures were constructed by milling prepolymerised PMMA resin discs CADCAM PMMA MODs while the third groupIII included 10 participants received conventionally constructed heat-cured poly methyl methacrylate mandibular PMMA overdentures conventional PMMA MODAll needed adjustments were executed at the insertion visit This is to assure appropriate border extension proper denture base fit even occlusal contact besides patient comfort The female housing attachment was picked up to the fitting surface of the mandibular overdenture bases using self-cure acrylic resin The white processing cap was removed and replaced by a blue one The mandibular overdentures were delivered to all participants according to their group
Patients evaluation Clinical evaluation Peri-implant soft tissue changes as regards plaque bleeding and gingival scores were assessed employing the modified plaque index PI bleeding index BI and simplified gingival index GI respectively These indices were evaluated at prosthesis insertion T0 3 months T1 6 monthsT3 and 12 month T4 after insertion A calibrated pressure-sensitive plastic periodontal probe was utilized
The participants enrolled in the current study were randomly assigned to one of three groups based on the material and technique of their mandibular overdenture bases All participants were delivered new sets of conventional complete dentures implied bilateral balanced occlusal scheme They were well instructed to wear their dentures regularly for 3 months prior to implant installment ascribed to enhancement of the neuromuscular adaptation For each patient the mandibular denture was duplicated with clear auto- polymerizing acrylic resin to fabricate the mandibular surgical template with gutta percha markers By employing CBCT all patients were scanned conforming to the dual scan protocol The implants were installed virtually parallel to each other and perpendicular to the occlusal plane at the areas of canines and lateral incisors This was carried out using 3D image planning software The surgical stent with four sleeves was constructed by rapid prototyping It was placed over the proposed implant locationsFour dental implants were surgically placed in the anterior region of the mandibleThree months afterward the mandibular impression was registered The primary impression was recorded and poured to gain the primary cast Upon that primary cast a closed custom tray was constructed The positioner attachments were screwed to the implants the processing caps and metal housings were secured over them The custom tray was border molded By using silicon impression material the definitive impression was made at the abutment level The processing caps and the metal housings were removed from the impression which was being poured by extra hard scannable dental stone to obtain the master cast Maxillomandibular relations were registered This was accomplished with mandibular conventional record blocks opposed by the existing maxillary complete denture Semi anatomical acrylic teeth were arranged employing bilateral balanced occlusion The waxed overdentures were tried in the patients mouth According to the mandibular denture base material and processing technique of the prostheses the subjects were divided into three groups The first group I included 10 participants whose mandibular overdentures were fabricated by milling pre-polymerized poly ether ether ketone PEEK discs CADCAM PEEK MODs the second groupII included 10 participants whose mandibular overdentures were constructed by milling prepolymerised PMMA resin discs CADCAM PMMA MODs while the third groupIII included 10 participants received conventionally constructed heat-cured poly methyl methacrylate mandibular PMMA overdentures conventional PMMA MODAll needed adjustments were executed at the insertion visit This is to assure appropriate border extension proper denture base fit even occlusal contact besides patient comfort The female housing attachment was picked up to the fitting surface of the mandibular overdenture bases using self-cure acrylic resin The white processing cap was removed and replaced by a blue one The mandibular overdentures were delivered to all participants according to their group
Patients evaluation Clinical evaluation Peri-implant soft tissue changes as regards plaque bleeding and gingival scores were assessed employing the modified plaque index PI bleeding index BI and simplified gingival index GI respectively These indices were evaluated at prosthesis insertion T0 3 months T1 6 monthsT3 and 12 month T4 after insertion A calibrated pressure-sensitive plastic periodontal probe was utilized
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None