INTRODUCTION:

Dental implants are used to repair damaged dentition as well as missing teeth. Due to the fact that they offer an alternative to traditional prosthetic therapy with long-lasting effects, dental implants have become popular as a treatment option. They have a number of benefits over fixed partial dentures, including not affecting the neighbouring teeth, which lowers the danger of decay and the possibility of an uncemented restoration, enhances hygiene, preserves bone, and lessens the possibility of neighbouring tooth loss.^1,2,3

They have a track record of delivering stable, long-term results for patients.^4,5

            The osseointegration of dental implants with bone was thought to require the submerged healing time of about 3 to 4 months. With time, the paradigm has evolved towards placing dental implants at the same time as extracting teeth from newly created extraction sockets. Immediate implant implantation is the name of this procedure. A reduction in the amount of time before the recovery of the masticatory function is one benefit of immediate implant insertion. As an alternative to the traditional delayed implant placement suggested by Branemark, immediate implant insertion was introduced in 1976.⁶

Single-tooth implants are increasingly being placed in the aesthetic zone right away after a failing tooth is extracted, preferably in conjunction with immediate provisionalization. This  keasl has been shown to cause slightly less peri-implant bone loss than immediate placement and delayed provisionalization, likely as a result of the additional surgical procedure.

Several authors placed dental implants in extraction sockets using immediate loading protocols (primarily an immediate loading of temporary restorations) in order to maintain a good aesthetic profile of the tissue volume contour around implants supporting fixed prostheses, and they reported excellent survival rates. ⁷

When a tooth is pulled, the peri-implant area’s hard tissue volume may diminish, which could cause the gingival contour to noticeably constrict.⁸

            The morphology of the tissues surrounding a dental implant depends primarily on characteristics of the alveolar bone as well as the prosthetic-implant restoration, and a proper interim crown may offer a quick and accurate anatomical shell structure that provides natural support to the soft tissues after tooth extraction.⁹

            The tissue-maintaining healing procedure could be started by an interim restoration that has been shaped to match the extracted tooth’s cervical morphology.¹⁰

            The sculpting of the soft tissue surrounding the implant, which is crucial in the cosmetic zone, is another critical stage in an interim repair. Several methods have been suggested for creating an implant-supported temporary repair that can be placed either intraorally or externally.¹¹

Bielemann et al., (2017)¹² conducted study is to improve the understanding of interleukin mechanisms during osseointegration to enhance the monitoring of implant failure and success. Clinical parameters, implant stability, and cytokine levels in peri-implant crevicular fluid (PICF) during early bone healing after implant placement were investigated. Clinical measurements of peri-implant health were also recorded. Samples from the PICF were collected 1, 2, 4, 8, and 12 weeks after surgery and analyzed for IL-1β, IL-6, IL-10, and TNF-α levels using ELISAs. They concluded that while the clinical measurements presented differences between the evaluation periods, these were not indicative of early dental implant failure or peri-implant diseases. Smoking, bone atrophy, and bone type can greatly influence the cytokines concentrations during the healing timing.

            Since it attracts neutrophils to the inflamed region and is typically produced by bacterial antigens, the inflammatory cytokine interleukin-1 beta (IL-1) is very effective. It has also been proposed and employed as one of the primary markers of acute inflammation. IL-1 appears to be a key player in the inflammatory response among the many cytokines involved in the induction and regulation of host responses in inflammation.¹³

            While the pink aesthetic score and white aesthetic score (PES & WES) concentrate on both soft tissue and tooth, the pink aesthetic score (PES) concentrates on the peri-implant soft-tissue assessment. Ten PES & WES parameters were used in this study, five of which were related to soft tissues (mesial papilla, distal papilla, curvature of facial mucosa, level of facial mucosa, and root convexity along with soft-tissue colour and texture), and five of which were related to restorations (colour [hue and value], outline and volume, tooth form, surface texture, and translucency or characterization).

AIM AND OBJECTIVE

Aim

·       Comparative evaluation of mean crestal bone loss, esthetic scoring and IL-1 beta level in provisional crown.

Objectives

·       To compare mean crestal bone loss between PMMA (Poly Methyl Methacrylate) crown and COMPOSITE RESIN crown.

·       Analysis of periimplant cravicular fluid cytokine levels (IL-1beta) between PMMA (Poly Methyl Methacrylate) crown and COMPOSITE RESIN crown.

·       To compare pink & white esthetic score between PMMA (Poly Methyl Methacrylate) crown and COMPOSITE RESIN crown.

RESEARCH HYPOSTHESIS

Null hypothesis

            The present study will be based on the hypothesis that there will be no difference between PMMA (Poly Methyl Methacrylate) crown and COMPOSITE RESIN crown on mean crestal bone loss, release of inflammatory biomarker (IL-1 beta) and pink & white esthetic score in immediate loaded implant.

REVIEW OF LITERATURE

James S. Marcum et al., (1967)¹⁴

Conclusion: The least inflammatory reaction was generated by crowns with margins that were at or even along the gingival crest; the largest inflammatory response was caused by crowns with margins above and below the crest. The degree or intensity of inflammation had little to no bearing on how long a restoration had been in situ. Many criteria must be considered while determining the ideal crown marginal depth. The findings of this study suggest that gingival inflammation would be least likely to occur with crowns that have borders finished even with the gingival crest.

Antonio Barone et al., (2006)¹⁵ 

            Presented a clinical case, the observed marginal bone level change around the experimental implants was low (0.42–0.4 mm). The reduced change of bone level in this study could be explained by the spontaneous healing of the bone defect between the implant and residual extraction socket walls. The width of keratinized gingival was measured before tooth extraction and 12 months after implant placement. A moderate recession of gingival margin was observed at the 12 month visit (within our clinical expectation), and all patients were fully satisfied with the esthetic results.

Juodzbalys G et al., (2007)¹⁶

            Data from the study indicated an 89.6% (SD 7.9%) mean vertical defect reduction after immediate implant placement into an extraction socket. Immediate crown placement ensured sufficient vestibular keratinized mucosa width (more than 2 mm) in 92.9% cases and good emergence crown alignment was achieved.

Laurens den Hartog et al., (2009)¹⁷

Conducted a report describes an immediate loading protocol finalized with the placement of a cement-retained all ceramic restoration, a substantial maturation of the papillae occurred during the provisional phase.

Todd R. Schoenbaum et al., (2013)¹⁸

Presented a clinical case demonstrating that placement of an implant into the extraction socket along with the fabrication and placement of an immediate provisional restoration is advantageous because it provides the opportunity to develop and support surrounding peri-implant tissues (particularly the interproximal papilla and marginal gingiva) from the time of extraction.

            Malchiodi L et al., (2013)¹⁹ This prospective study presents the esthetic outcomes of 64 anterior maxillary single-tooth implants inserted according to the concepts of immediate postextractive placement and immediate loading of implants. The predictability of these techniques was demonstrated in the present study by the very high 100% implant success rate with preservation of soft tissue profile and crestal bone level.

Montserrat Boronat-Catalá et al., (2014)²⁰

            Stated that all the interleukins studied to date in crevicular fluid and/or the saliva of patients with gingivitis, IL-1b has been the most analyzed and that the majority of authors (70%) that have investigated it in their studies agree that it is higher in situations of gingivitis and experimental gingivitis. As far as the other interleukins studied are concerned: IL-12, IL-8, IL-11, IL-4, TNFa, IL-18,IL-17, IL-1a, and IL-6, we have not found a consensus among the authors and their results do not coincide sufficiently so as to classify them as diagnostic markers of degrees of inflammation.

Giovanni-Battista Menchini-Fabris et al., (2019)²¹

The findings from this study showed that immediate restorations of implants placed in fresh extraction sites can provide a safe and successful treatment procedure.

Meng, Hsiu-Wan et al (2021)²²

In his study examined Immediate implant placement and provisionalization in a fresh extraction socket is challenging and requires careful case selection. In general, the soft tissue contour of the extraction socket should closely mimic that of adjacent natural teeth without vertical soft tissue deficiency. Furthermore, the keratinized gingival width on the midbuccal aspect of the socket should be ≥2mm, with a thick gingival biotype (≥2mm). The apical bone beyond the extraction socket should be ≥4mm to achieve primary stability of the implant. The tip of the mesial and distal papillae should lie between the interdental contact and the most coronal extent of interproximal CEJ. 

MATERIALS AND METHODS

Self-reporting patients visiting Department of Prosthodontics and Crown & Bridge, Faculty of Dental Sciences, King George’s Medical University, Lucknow, for rehabilitation of edentulous space in maxillary arch that could be restored with an implant supported single unit crown will be screened as per inclusion and exclusion criteria.

Ethical approval will be taken from institutional ethical committee. We will register this study in clinical trial registry of India at www.ctri.nic.in after ethical approval and before enrolling first participant.

Inclusion Criteria

·       Adult patients (age between 18 to 70 years).

·       Adequate bone volume to allow placement of implant.

·       Patients without reported defect of bony wall.

·       No chronic and systemic disease

Exclusion Criteria

·       Untreated caries/ Periodontal Diseases in Residual dentition.

·       Medically compromised patients (any past records of Uncontrolled Diabetes, radiation, Chemotherapy treatment, psychological problems), Severe bruxism cases and any TMD cases.

·       Patients under systemic corticosteroids or Bisphosphonates therapy.

·       Severe intermaxillary discrepancy

·       Poor oral hygiene

·       Sever parafunctional habits

·       Heavy smoking habit ( > 10 cigarettes per day)

·       Alcohol or drug abuse

Sample Size at 90% Power

·       Sample size is calculated on the basis of variation in crestal bone loss change from baseline to last follow up using the formula.

·       Where  s₁ = 0.7, The SD of buccal palatal width change from baseline to last follow up in the first group

s₂ = 1.2,  The SD of buccal palatal width change from baseline to last follow up in the second group

(Ref. Menchini-Fabris GB et al)

·       d = max(s₁, s₂), the minimum difference considered to be clinically significant

k = 1.2 the design effect

·       type I error α = 5% corresponding to 95% confidence level

type II error β = 10% for detecting results with 90% power of study

So the required sample size

n = 20 each group

Study Design- Randomized controlled trial

Randomization-Participants fulfilling the eligibility criteria will be randomized using computer generated random number using www.randomizer.org.

Allocation of crown will be concealed using opaque sealed envelope before giving either PMMA or composite crown.

Blinding This study will be participants, outcome assessor blinded randomized controlled trial.

Participants will not be able to differentiate between interventions as there is no accessible difference in surgical protocol in both groups.

Outcome access or will be blinded as mean crestal bone loss, cytokine levels (IL-1beta) and pink & white esthetic score assessment will not reveal to the patient.

Only the operator will know the treatment protocol employed for the patient.

Intervention

IL group (Immediate Loading) (n =20): This group will receive prosthesis within 48 hours of implant placement, PMMA (Poly Methyl Methacrylate) crown.

IL Group (Immediate Loading) (n=20) : This group will receive prosthesis within 48 hours of  implant placement, composite resin crown.

Surgical Protocol for both Intervention groups

After taking a proper medical, dental history, clinical and radiographic examination. Informed consent will be obtained from each participant selected for the study. Prophylactic antibiotic coverage of 2 gm Amoxycillin will be given to all the subjects 1 hour before the procedure. After local anaesthesia will be induced with 2% lignocaine with adrenaline (LOX 2% Adrenaline), a crestal incision will be made and the mucoperiosteal flap will be raised. Implants will be placed according to recommendations given by manufacturer.

EVALUATION OF THE LEVELS OF IL-1β 

The collection of peri-implant crevicular fluid (PICF) will be performed immediately after implant placement (baseline). The PICF collection will be done using standardized paper strips (Periopaper™). Two strips of paper will be subsequently inserted separately in the mesial and distal periimplant sulcus. Each strip will remain in the peri-implant sulcus for 40 s, and a 40-s interval was applied between the insertion of both strips. After collection, both strips will be inserted into a single Eppendorf vial containing 100 μl of phosphate buffered saline and stored at – 80 °C. Interleukins IL-1β will be quantified using enzyme-linked immunosorbent assay (ELISA) kits following the procedures recommended by the manufacturer. Cytokine levels will be assessed by a micro-ELISA reader at regular intervals for both groups. All analyses will be performed by a blinded technician.

Evaluation of Pink & White Score 

Pink and white esthetic scores (PES and WES) were developed in an attempt to allow objective evaluation of esthetics in implant dentistry. However, esthetic outcomes should measure both an objective assessment by the clinician and a subjective evaluation by the patient.

EVALUATION OF MEAN CRESTAL BONE LOSS

Post-operative digital IOPA will be made to record exact bone level at time of implant placement. Routine postoperative evaluation will have to be conducted.

Post restoration radiograph will be made shortly after the restoration at–

1.         GROUP 1  Baseline, 2 months, 3 months.

2.          GROUP 2 Baseline, 2 months, 3 months

Marginal bone loss calculated using Calibrated IOPA via Image J Software. All measurements will be then exported into an excel spreadsheet for analysis. The mesial and distal mean crestal bone length will be standardized with a known mid-axis implant length. Mesial and distal mean crestal bone length will be averaged and then mean bone level changes will be computed.

Data management and analysis

Statistical Analysis 

            SPSS latest available version and MS Excel will be use for statistical analysis of the data. The Kolmogorov-Smirnov test will be applied to check whether the data fits normal distribution, Continuous variables conforming to a normal distribution will be expressed as mean ± standard deviation, continuous variables not conforming to normal distribution will be expressed as median and inter-quartile range. Counting data will be expressed as number and percentages. The independent-samples t-test will be used for inter-group analysis of quantitative data such as age, height, weight etc. The χ2 test will used to compare the proportion data between the groups and the intubation accuracy of the two groups. Other appropriate statistical tests will be used. In all of the statistical analyses, P < 0.05 will be considered to be statistically significant.

If any change deemed necessary then it will be done during study.

We will report Participant flow according to consort flow diagram.