Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06349525
Other study ID # DU-2021-00103
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date October 1, 2023

Study information

Verified date March 2024
Source Delta University for Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Forty patients ( 24female and16 male )with completely edentulous maxilla and mandible . All patients received implant supported mandibular and maxillary overdentures. The patients were randomly divided into two groups according to attachments retaining Max IOD that supported by four axial implants in maxilla . The TA was used to retain group I (GrI) MaxIOD , while that of group II (Gr II) was retained by LA. MaxIOD retention and MBL(vertical and horizontal) around implants of both groups was recorded at time of insertion (R0) ,then twelve(R12)and (R24) months following insertion of the prosthesis.


Description:

Parallel groups, two arms, randomized controlled trial (RCT) with 1:1 allocation ratio was designed, retention of telescopic attachment and locator attachment among patients with completely edentulous maxillary arch and intended to use maxillary overdenture was compared. The minimum proper sample size was 20 participants in each group to be able to detect a real difference in retention equal to 2 N with 80% power at α = 0.05 level using Student's t test for independent samples. The stone casts were poured and mounted guided by the the occlusion of upper and lower dentures in centric relation to evaluate inter-arch distance. Pre-operative panorama was initially made to assess bone quality and quantity of edentulous maxillary ridge New Complete maxillary and mandibular dentures were made using semi-anatomic teeth arranged following balanced occlusion . The stent is scanned in the patient's mouth using CBCT. DICOM (digital imaging and communications in medicine) was applied for the virtual planning of the implants using exocad software . Two virtual implant models were used and their criteria are mentioned (in table 2). Implants were planned at lateral-canine areas equidistant from midline and another two implants at first molar bilaterally . A safety zone of a minimum of 2 mm between the implants and vital structures like the maxillary sinus was planned Surgical procedure Two stage surgical protocol was followed for insertion of implants for both groups in their planned position via the same oral and maxillofacial surgeon. Presurgical prophylactic medications were prescribed, including: 1gm Augmentin®, prednisone, and 0.2% chlorhexidine digluconate started 8 hours before surgery and continued for 7 days following surgery. Analgesic drug was prescribed once daily or when needed. Flapless surgical technique was followed guided by mucosa-supported surgical stents that were checked intraorally for stability and fitness. The stents were fixed to the bone using three fixation screws. Implants were inserted at a minimum of 35 Ncm torque. After complete insertion of fixtures and screwing of covering abutments , tissue conditioner was used for relining and fitting of the existing maxillary denture to the mucosa. Participants were instructed to eat a soft diet and perform oral hygiene procedures.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 1, 2023
Est. primary completion date July 5, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria: - have sufficient bone volume(classes IV to VI, Cawood and Howell) and quality (classes I to III, Lekholm and Zarb) - be fully edentulous for at least 1 year and did not have an American Society of Anesthesiologists score (ASA) of IV or higher. - be with Angle Class I maxillo- mandibular relationship - have Adequate zone of keratinized attached mucosa >5mm over the crest of the upper and lower ridge - have adequate inter-arch space (22 mm) as determined by the mounted casts carrying the patient upper and lower complete dentures . Exclusion Criteria: - Any medical disorders that could complicate the surgical phase or affect osseointegration as osteoporosis, uncontrolled diabetes and hypertension - Smoking; - Former radiotherapy in the head and neck region - Former pre-prosthetic surgery or loss of implants in the maxilla - Patients with para-functional habits (as clenching or bruxism) - Hard tissue augmentation / grafting.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
telescopic overdenture
Maxillary implant supported telescopic overdenture
Locator overdenture
Maxillary implant supported locator overdenture

Locations

Country Name City State
Egypt Delta University for Science & Technology Mansoura

Sponsors (1)

Lead Sponsor Collaborator
Delta University for Science and Technology

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retention Retention was measured by a digital force gauge device (Extech's Model 475055 Digital Force Gauge FLIR Commercial Systems, Inc.) that measures tension or compression force (pull/push) to values of up to 980 Newton.25 The snap hook of the device engaged a screw fixed to the geometric center of denture bases using self-cure acrylic resin. Then pulling action was applied till the denture separation recording the amount of retention in Newton. 1 month, 12 months, and 24 months
Secondary Marginal bone loss Digital periapical radiographs were made using a direct digital imaging system (Digora Optime, Orion Corp./Soredex). Standardization of film position was done by fixing the film positioner to the implants using the placement aid of the implants. The digital images were traced using the accompanying software, and vertical and horizontal bone losses were measured 12 months and 24 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06408506 - In-patient Comparison of Immediately Loaded and Non-loaded Submerged and Transgingival Healed Implants Within 4 Months N/A
Active, not recruiting NCT05355792 - Multicenter Study to Evaluate the Clinical Outcome of the OmniTaper EV Implant in Single Tooth Restorations N/A
Terminated NCT00748670 - Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-Stage Surgery N/A
Completed NCT04873219 - Milled Versus Printed CAD/CAM Complete Dentures N/A
Active, not recruiting NCT04545840 - Prospective Neodent® Zirconia System Study
Completed NCT00922935 - Comparison of Early and Late Loading in the Edentulous Upper Jaw Using Cresco Prosthetic System on Straumann Implants Phase 4
Completed NCT00905840 - A Study to Treat Patients With Edentulous Mandibles With Two Straumann 3.3mm Diameter Bone Level Implants N/A
Completed NCT00959530 - Comparison of Lingualized and Full Bilaterally Balanced Articulation N/A
Completed NCT00711022 - Study on ASTRA TECH Implant System, OsseoSpeed™ Implants in Patients Missing All Teeth in the Upper Jaw, Restored With Provisional Teeth Within 24 Hours N/A
Terminated NCT00295126 - REPI : a Randomized Open Label Trial Evaluating the Use of APC in Pre-Implantation Reconstruction of Maxilla Phase 2/Phase 3
Recruiting NCT03957265 - Prospective Observational Study of SynCone® Concept Phase 1
Completed NCT01909999 - Release of Osteogenic Markers in Immediately and Non-loaded Dental Implants N/A
Completed NCT00901017 - Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation N/A
Completed NCT01641198 - An Implant With an Acid-etched Fixture Surface and Internal-hex Collar May Achieve Greater Osseointegration. N/A
Completed NCT03862482 - Peri-Implant Healing Around Two Different Machined-Collar Designs After 25 Years of Function N/A
Completed NCT01878331 - Long-term Study to Evaluate Different Dental Implant Alloys in Straumann 3.3mm Diameter Bone Level Implants
Completed NCT02418117 - Accuracy of Computer Guided Implant Surgery N/A
Completed NCT02107612 - Randomized Study For Minimally Invasive Splinted Implants N/A
Active, not recruiting NCT05007691 - Comparative Study of Maxillary and Mandibular Splints Used for the Treatment of Masticatory Muscle Parafunction (FEA) N/A
Active, not recruiting NCT04328116 - Study of Neodent Implantable Devices of GM Zygomatic Line