Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06349525
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2024-04-01
Brief Title:
Retention of Telescopic Versus Locator Attachments
Sponsor:
Delta University for Science and Technology
Organization:
Delta University for Science and Technology
Study Overview
Official Title:
Retention of Telescopic Versus Locator Attachments And Marginal Bone Loss Surrounding Implants Supporting Maxillary Over-dentures Two Year Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 MBLvertical and horizontal around implants of both groups was recorded at time of insertion R0 then twelveR12and R24 months following insertion of the prosthesis
Detailed Description:
Parallel groups two arms randomized controlled trial RCT with 11 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 005 level using Students 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 patients 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 02 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
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 patients 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 02 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None