Trial no.:	PACTR202108872564649	Date of Approval:	16/08/2021
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Staged ARST vs.immediate ARST with short implant in the posterior mandible

Official scientific title

Evaluation of Radiographic crestal bone resorption in staged alveolar ridge splitting vs. immediate alveolar ridge splitting using piezotome with short implants in the posterior mandible: 3-4 year follow-up RCT

Brief summary describing the background and objectives of the trial

Attempts in replacing missing lower posterior teeth with endosseous implants and fixed prosthodontics has always been a challenge, due to the passage of the inferior alveolar nerve within the body of the mandible limiting the amount of available vertical and horizontal bone. Horizontal and vertical bone augmentation techniques have been immensely introduced in the literature to solve such obstacle of limitation of available ridge, with the horizontal augmentation showing extensively better results than vertical augmentation creating the vertical bone augmentation taboo of fear from failure after extensive surgery. multiple studies have shown satisfactory results when using short wide implants than attempts of vertical bone augmentation. With the use of such wide implants further horizontal ridge enlargement might be needed more than the normal 6mm bucco-lingual width prepared for regular implants. One of the well documented ridge expansion techniques is alveolar ridge splitting with the mere advantage of a shorter surgical treatment time , a total decrease in treatment period and a decrease in the patient¿s financial load. Usage of Piezoelectric surgical cutting devices in the ridge splitting technique has shown better results in terms of higher success rates and lower intraoperative complications. Still the mandibular posterior cortical bone creates a sort of hesitation when discussing ridge splitting due to the incidence of intraoperative bone plate fracture or dehiscence. Therefore a staged or delayed splitting technique was introduced to decrease such fear showing preliminary acceptable results. No RCT has been performed to show the added qualities of staged ridge expansion with plenty of clinical trials describing both the immediate and staged technique separately. Although some studies had a mixture of both techniques the difference was never articulated. For such periapical and CBCT scans will be us

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

missing lower posterior teeth with horizontal and vertical bone loss

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Other

Anticipated trial start date

15/11/2014

Actual trial start date

15/02/2015

Anticipated date of last follow up

15/02/2016

Actual Last follow-up date

04/03/2020

Anticipated target sample size (number of participants)

34

Actual target sample size (number of participants)

21

Recruitment status

Completed

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Simple randomization using a randomization table created by a computer software program	Sealed opaque envelopes	Masking/blinding used	Care giver/Provider,Outcome Assessors,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Staged ridge splitting	-	5 years follow up - with 1 year and 3 year and 5 year results	piezoelectric ridge splitting in the first surgery. Minimal flap opening with expansion and implant placement in second surgery.	17
Control Group	simultaneous ridge splitting and implant placement		5 year follow up, with 1 year, 3 year and 5 year results	Full thickness flap, piezo electric splitting and immediate short implant placement	17	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Partially edentulous patients with missing teeth in the posterior mandibular region. Posterior mandibular ridge width (3 - 5 mm) and height from inferior alveolar nerve ( ¿ 11 mm). Absence of any pathological conditions in the posterior mandible (recipient site).	1- Systemic diseases. 2- Poor oral hygiene. 3- No or poor compliance with non-surgical phase of treatment. 4- Pregnant females. 5- Regular and heavy smokers. 6- Previous head and neck radiation therapy. 7- Patients with an allergy to any material or medication that will be used in the study. 8- Severe psychological problems.	80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s)	20 Year(s)	80 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

04/11/2014

Cairo University dental school ethics commity

Ethics Committee Address
Street address	City	Postal code	Country
El Manial st., El Manial	Cairo	00203	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Crestal Bone resorption	Radiographic evaluation of the implant site via standardized digital periapical radiographs by measuring (T2 ¿ T1) which indicates the first 4 months prior to loading and (T3 ¿ T2) which indicates 6 months after loading
Secondary Outcome	Crestal bone resorption:	Standardized CBCT scans would also augment such investigation by measuring (T3 ¿ T1).

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
MSA university	El Wahat road	6th of October		Egypt
Moussa Dental clinic	5 Brazil st., Zamalik	Cairo	00202	Egypt
Al kasr El Aini Dental School outpatient clinic	El Manial St., El Manial	Cairo	00202	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Principal investigator Mahmoud Moussa	5 Brazil st., zamalik	Cairo	00202	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Cairo University	El Manial	Cairo	00202	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country
Dr. Hany El Nahass	El Maadi	Cairo	00202	Egypt
Dr. Omnia About El Dahab	El Giza	El Giza	00202	Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Mahmoud Moussa	dr.mmoussa@rocketmail.com	002-1006392667	27 El Jazeera El Wusta, El Zamalik
City	Postal code	Country	Position/Affiliation
cairo	00202	Egypt	Assistant lecturer
Role	Name	Email	Phone	Street address
Public Enquiries	Hani El Nahass	nahass77@gmail.com	000000000000	El Maadi
City	Postal code	Country	Position/Affiliation
Cairo	00202	Egypt	Assistant Professor
Role	Name	Email	Phone	Street address
Scientific Enquiries	Omnia Abou El Dahab	odahab@gmail.com	0000000000	El Giza
City	Postal code	Country	Position/Affiliation
Giza	00202	Egypt	Professor

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	All of the individual participant data collected during the trial, after deidentification	Study Protocol	Immediately following publication, No end date	Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

Pan African Clinical Trials Registry