Retention of Telescopic Versus Locator Attachments

NCT ID: NCT06349525

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-10-01

Brief 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.

Detailed 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.

Conditions

Jaw, Edentulous

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

4 implants overdenture with telescopic

Completely edentulous maxillary arch treated with 4 implants overdenture

Group Type: EXPERIMENTAL

telescopic overdenture

Intervention Type: DEVICE

Maxillary implant supported telescopic overdenture

4 implant supported overdenture with Locator

Completely edentulous maxillary arch treated with 4 implant supported overdenture

Group Type: ACTIVE_COMPARATOR

Locator overdenture

Intervention Type: DEVICE

Maxillary implant supported locator overdenture

Interventions

telescopic overdenture

Maxillary implant supported telescopic overdenture

Intervention Type: DEVICE

Locator overdenture

Maxillary implant supported locator overdenture

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Delta University for Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wafaa I Ibrahim

Role: PRINCIPAL_INVESTIGATOR

Assoc. Prof.

Locations

Delta University for Science & Technology

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

DU-2021-00103

Identifier Type: -

Identifier Source: org_study_id