PMID- 33949960
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210525
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 10
IP  - 5
DP  - 2021 May 5
TI  - Assessment of Outcomes of Immediately Loaded Dental Implants in Orofacial Cleft 
      Patients: Protocol for a Single-Arm Clinical Trial.
PG  - e25244
LID - 10.2196/25244 [doi]
LID - e25244
AB  - BACKGROUND: Orofacial cleft, one of the most common congenital deformities, 
      presents with a plethora of defects, subjecting the patient to a multitude of 
      treatments from a young age. Among the oral hard tissue problems, absence of a 
      maxillary permanent tooth in the cleft region either due to congenital absence or 
      extraction due to compromised prognosis is a common finding. Conventionally, the 
      missing tooth is replaced using a removable or fixed partial denture; however, 
      the treatment modality does not satisfactorily meet patient expectations. The 
      most recent decade has seen increasing use of dental implants in the cleft 
      region; however, the outcome of an immediately loaded dental implant is still 
      elusive for orofacial cleft patients. OBJECTIVE: This protocol is for a 
      single-arm clinical trial aimed at determining the treatment outcome of 
      immediately loaded dental implants in patients with a nonsyndromic orofacial 
      cleft. METHODS: Patients meeting the set criteria will be sequentially enrolled 
      until a sample size of 30 dental implants is met and will undergo the proposed 
      treatment according to the predecided protocol. All patients will be followed up 
      at the designated time intervals to record various clinical and radiographic 
      parameters. Implant success will be defined based on the criteria elucidated by 
      Misch et al in the Pisa, Italy Consensus. A quality-of-life assessment 
      questionnaire will also be recorded at the end of patient's follow-up to 
      determine their acceptance of the treatment. RESULTS: A total of 30 dental 
      implants will be placed in patients with a nonsyndromic orofacial cleft. Obtained 
      results will be statistically analyzed to determine the treatment outcomes and 
      success. CONCLUSIONS: This study will help determine the feasibility of 
      immediately loaded dental implants in compromised bone sites such as those 
      presented in cleft patients and will help in generating findings that can be used 
      to fill the lacunae currently present in the holistic treatment of cleft 
      patients. TRIAL REGISTRATION: Clinical Trial Registry of India 
      CTRI/2020/09/027997; 
      http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=47659&EncHid=&userName=dental%20implants. 
      INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/25244.
CI  - (c)Rizwana Mallick, Sweta Kale Pisulkar, Srinivas Gosla Reddy. Originally published 
      in JMIR Research Protocols (https://www.researchprotocols.org), 05.05.2021.
FAU - Mallick, Rizwana
AU  - Mallick R
AUID- ORCID: 0000-0002-3027-2301
AD  - Department of Prosthodontics and Crown & Bridge, Faculty of Dentistry, Jamia 
      Millia Islamia, New Delhi, India.
FAU - Pisulkar, Sweta Kale
AU  - Pisulkar SK
AUID- ORCID: 0000-0003-2794-4944
AD  - Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Deemed to 
      be University, Wardha, India.
FAU - Reddy, Srinivas Gosla
AU  - Reddy SG
AUID- ORCID: 0000-0001-9720-5501
AD  - GSR Institute of Craniomaxillofacial and Facial Plastic Surgery, Hyderabad, 
      India.
LA  - eng
PT  - Journal Article
DEP - 20210505
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC8135029
OTO - NOTNLM
OT  - clinical trial protocols
OT  - dental implants
OT  - dentistry
OT  - immediate dental implant loading
OT  - implant-supported dental prosthesis
OT  - mouth rehabilitation
OT  - oral health
OT  - orofacial cleft
OT  - quality of life
OT  - rehabilitation research
OT  - treatment outcome
COIS- Conflicts of Interest: None declared.
EDAT- 2021/05/06 06:00
MHDA- 2021/05/06 06:01
PMCR- 2021/05/05
CRDT- 2021/05/05 12:25
PHST- 2020/10/24 00:00 [received]
PHST- 2021/02/24 00:00 [accepted]
PHST- 2021/01/14 00:00 [revised]
PHST- 2021/05/05 12:25 [entrez]
PHST- 2021/05/06 06:00 [pubmed]
PHST- 2021/05/06 06:01 [medline]
PHST- 2021/05/05 00:00 [pmc-release]
AID - v10i5e25244 [pii]
AID - 10.2196/25244 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2021 May 5;10(5):e25244. doi: 10.2196/25244.