Treatment Outcome of Short Implant Assisted Mandibular Overdenture

Atrophy of Edentulous Mandibular Alveolar Ridge Clinical Trial

Official title:

Treatment Outcome of Short Implant Assisted Mandibular Overdenture in Combination With Low Level Laser Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03540316
• Other study ID #: 01032018
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: January 2024

Study information

• Verified date: July 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the use of short dental implants to support mandibular overdenture together with the use of laser therapy for treatment of patients with atrophic ridges. All participants will receive laser therapy; half of participants will receive two short implants and the other half will receive four short implants.

Description:

The conventional solution to complete edentulism is the use of complete removable dentures. One negative effect of edentulism is resorption of the edentulous ridge over time. Construction of a successful mandibular complete denture for patients with advanced mandibular ridge resorption is often difficult and on some occasions virtually impossible. It has been proved that when implants are placed, bone gets stimulated resulting in minimal bone loss. But anatomic limitations to implant placement have been observed in atrophic ridges, so short implants introduced as a recent alternative to aggressive surgical procedures proposed to compensate for tissue deficiency. Also, Low Level Laser Therapy (LLLT) has proven success in improving implant stability which is very crucial in short implants. Thus, the purpose of this study is to evaluate and compare the treatment outcome of mandibular overdenture assisted by two short implants versus that assisted by four short implants in combination with LLLT.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Completely edentulous patients.

• Patients with mandibular resorbed edentulous ridge.

• Medically fit patients with no systemic conditions.

• Class I ridge relation.

• Adequate zone of keratinized mucosa.

Exclusion Criteria:

• Metabolic bone disease or unstable systemic condition.

• Heavy smokers.

• A history of radiotherapy in the head and neck region.

• Physical or mental disability.

• Temporomandibular and neuromuscular disorders.

Related Conditions & MeSH terms

• Atrophy
• Atrophy of Edentulous Mandibular Alveolar Ridge

Intervention

Combination Product:
• Two short implants and 2 minutes LLLT
Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 2 minutes.
• Two short implants and 4 minutes LLLT
Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 4 minutes.
• Four short implants and 2 minutes LLLT
Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 2 minutes.
• Four short implants and 4 minutes LLLT
Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 4 minutes.

Locations

Country	Name	City	State
Egypt	Faculty of dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Sara Zayed

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Maló P, de Araújo Nobre M, Rangert B. Short implants placed one-stage in maxillae and mandibles: a retrospective clinical study with 1 to 9 years of follow-up. Clin Implant Dent Relat Res. 2007 Mar;9(1):15-21. — View Citation

Mandic B, Lazic Z, Markovic A, Mandic B, Mandic M, Djinic A, Milicic B. Influence of postoperative low-level laser therapy on the osseointegration of self-tapping implants in the posterior maxilla: a 6-week split-mouth clinical study. Vojnosanit Pregl. 2015 Mar;72(3):233-40. — View Citation

Maniewicz S, Buser R, Duvernay E, Vazquez L, Loup A, Perneger TV, Schimmel M, Müller F. Short Dental Implants Retaining Two-Implant Mandibular Overdentures in Very Old, Dependent Patients: Radiologic and Clinical Observation Up to 5 Years. Int J Oral Maxillofac Implants. 2017 Mar/Apr;32(2):415-422. doi: 10.11607/jomi.5361. — View Citation

Thomason JM, Feine J, Exley C, Moynihan P, Müller F, Naert I, Ellis JS, Barclay C, Butterworth C, Scott B, Lynch C, Stewardson D, Smith P, Welfare R, Hyde P, McAndrew R, Fenlon M, Barclay S, Barker D. Mandibular two implant-supported overdentures as the first choice standard of care for edentulous patients--the York Consensus Statement. Br Dent J. 2009 Aug 22;207(4):185-6. doi: 10.1038/sj.bdj.2009.728. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of changes in implant stability (Implant Stability Quotient).	Implant stability can be defined as the absence of clinical mobility. It will be assessed at the time of implant placement (baseline) ,then six months and twelve months later, by the resonance frequency analysis using Osstel devise which measure implant oscillation frequency on the bone;Implant Stability Quotient (ISQ) .	Baseline, 6 months &12 months.
Secondary	Peri-implant marginal bone changes.	Radiographic assessment of bone level changes around each implant will be performed to detect peri-implant crestal bone changes using standardised digital periapical x-ray. It will be assessed at the time of implant placement, six months and twelve months later.	Baseline, 6 months &12 months.
Secondary	Assessment of changes in peri-implant probing depth .	Peri-implant probing depth is the distance between the gingival margin and the most apically probeable portion, in millimetres. It will be measured at four sites of each implant (mesially, labially, distally, lingually) by using a graduated periodontal probe which will be held parallel to the long axis of the implant and introduced to the peri-implant sulcus till there is slight resistance. The mean record for each implant will be calculated. It will be evaluated at time of definitive prosthesis insertion then, six months and twelve months after implant placement.	Baseline, 6 months &12 months.
Secondary	Assessment of changes in modified gingival index	To qualify the degree of peri-implant inflammation, the modified gingival index will be used. It will be measured at four sites around each implant (mesially, labially, distally, lingually) and the mean record for each implant will be calculated. It will be evaluated at time of definitive prosthesis insertion, then six months and twelve months after implant placement.	Baseline, 6 months &12 months.